Tuesday, October 27, 2009

Tumors as elusive targets of T-cell-based Active Immunotherapy..Melanoma..Jim Breitfeller

Dr. Herlyn, I been researching my successful Melanoma treatment and came across a research paper of yours “Tumors as elusive targets of T-cell-based active immunotherapy”. It postulates the mechanism underlying is the Antigen-Specific T-cell base immunotherapy can result in a complete response if activated appropriately. I believe that you diagram was right on target. My therapy was three clinical trials that followed your proposed mechanism. I did DTIC + PaTrin-2 to shed the right antigenic protein. Then I used Anti-CTLA-4 blockage to activate CD4+ T-cells and suppress the Tregs. IL-2 HD was added to help differentiate the T-cells and maintain there function and survival. Timing and dosing concentration played a major factor in breaking the balance of the tumor’s microenvironment. During my therapy I did get an inflammation response leading to a complete response.

Attached is a draft of what transpired and the dosing and timing. I believe this information might be very helpful in your research.
(See My Shared files)

"Melanoma and the Magic Bullet (monoclonal antibodies"

Fig. 2. Postulated mechanism underlying tumor antigen (TA)-specific T-cell-based immunotherapy and effect on target antigen expression. Localization of TA-specific
T cells at a tumor site appears to be necessary but not sufficient for tumor elimination [38,39]. If no response occurs, the interaction between T cell and tumor cell is
probably not sufficient (or sustained) to start or maintain an inflammatory process. If the treatment induces an adaptive response of a quality and/or intensity that exceeds
a certain ‘threshold’, then direct interaction of T cells with antigen-expressing (red circles) tumor cells leads to their destruction, as well as to the production of proinflammatory
and pro-apoptotic cytokines that induce secondary activation of adaptive and innate immune effectors capable of clearing tumor cells that have lost antigen
expression (white circles). If the tumor-cell destruction is not complete, the proliferation of remaining cells leads to recurrence. In those cases, the recurring tumors have
lost the surface expression of the epitope relevant to the vaccination [66,67]. Abbreviations: CR, complete response; PR, partial response; X, cells killed by the therapy.


Tumors as elusive targets of
T-cell-based active immunotherapy

Exposure To Antigen
As you can see, the maxium Antibody level occurs on day 20. My Inflamed response occurred on day 15. This all fits together.

Jim's Protocol complete response

Take Care,

Jimmy B

Friday, October 23, 2009

Bristol-Meyer Squibb, Show Us the Patients, the Master Production Batch Record (MPBR) or Production Batch Record (PBR) for Ipilimumab

Bristol-Meyer Squibb, If there was truly a Shortage/problem in the production of Ipilimumab, the it would show up in the Master Production Batch Record (MPBR) or Production Batch Record (PBR)

“A master production batch records (MPBR) is a detailed, step-by-step description of the entire production process for a specific drug. It is the document wherein the chemical and biological processes of drug manufacturing (developed during the phase of research and process development of the drug) are merged with the regulatory requirements of the FDA. A good batch record ensures the fundamentals of cGMP compliance while providing a practical set of instructions for the manufacturing technician or operator. The MPBR explains exactly how the product is produced, indicating specific types and quantities of components and raw materials, processing parameters, in-process quality controls, environmental controls, etc. To support the requirements of the production batch record (PBR) which is also known as the batch production and control record, the MPBR contains fill-in-the-blank spaces throughout the text to facilitate the documentation of events for each individual batch. In fact the PBR is an exact copy of an approved MPBR. A PBR is issued for each batch of product produced in the facility. A batch, by the way, is defined in the Code of Federal Regulations, Title 21 210.3: "Batch means a specific quantity of a drug or other material that is intended to have a uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacturing." For a cell-culture derived protein product, a batch begins with inoculation and then proceeds through harvest and purification (sometimes the final purification steps may have a separate batch record). There would be separate batch records for media preparation, equipment preparation (cleaning, assembly, sterilization, etc.), and scale-up for innoculum preparation. There would also be separate batch records for final product formulation, filtration, filling, lyophilization, sealing, inspection, and labeling. PBRs must be followed during production events, and the information and signature blocks must be completed as production proceeds. Production and QC personnel write the MPBR.”

This Document would be the proof that there was or wasn’t a shortage/problem.

We would also like a copy of the production log book ledger dating back to 7-1-2008.

Facts About Current Good Manufacturing Practices (cGMPs)http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm#


Take Care,

Jimmy B

Thursday, October 22, 2009

Why Should We Believe That There Was Even a Shortage of Ipilimumab?Melanoma ..Jim Breitfeller

On June 11, 2007, BMS agreed to plead guilty and pay a $1 million criminal fine for misleading the government about the Plavix patent deal. BMS paid the maximum fine permitted by statute for committing two violations under the federal False Statements Act."

They mislead Government officials so why would they tell us the Patients, the truth about the shortage?

April 25 2008

Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab

PRINCETON, N.J., April 25 2008 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS)data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.

As far as my research to date(10-22-2009), BMS/Medarex has not file a BLA with the FDA.

On September 12 2008 they closed the compassionate use for Ipilimumab

Your email was forwarded to us by CBER (this IND resides in the Center for Drugs Evaluation and Research). We have contacted BMS to check into the availability of ipilimumab and here is the information that BMS provided to us.

"To ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide ongoing supply to the registrational program, Bristol-Myers Squibb and Medarex have suspended enrollment of new patients into the compassionate use program, single patient exemptions and initiation of some non-registrational trials effective September 12, 2008.

Bristol-Myers Squibb and Medarex are working to manage the supply issue and may be able to re-open compassionate use in the future.

The companies are committed to providing uninterrupted treatment to patients who initiate therapy with ipilimumab. Therefore, if and when the compassionate use program reopens, it will be at such time when continuous and unconstrained supply is available."

Please let us know if you have any questions.

CDER Drug Shortage Team

It Takes about a month to make a batch of monoclonal antibodies. By the time the batch is tested and packaged and approved, let us allow another two months. So in a year you should be able to make 3 to 4 batches.

Melanoma Treatment Information - Updated 09.10.09

"Ipilimumab which ASCO reported some promising results had been widely available in compassionate use trials across the county until a shortage halted the studies. Bristol Myers Squibb, is now manufacturing the drug again and there are a few small “pharmacokinetic” trials to prove the agent is the same as the previous one used in trials. Most of these trials already have waiting lists, but it may be worth checking out. Screening started August 4th and you can find the locations on www.clinicaltrials.gov."


Melanoma International Foundation

Well come to find out that BMS/Medarex is opening up new clinical trials with Ipilimumab and continue to keep the compassionate use trial closed. How ethical is that?

When big pharma is involved in clinical development, it usually means large-scale clinical trials with patients and multiple sites.

Here are the trials:

Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Start Date: August 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00732186

Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Start Date: February 2009
Estimated Study Completion Date: Feb 2013
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00836407

Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
Start Date: February 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 33
ClinicalTrials.gov Identifier: NCT00790010

Laboratory-Treated T Cells With or Without Ipilimumab in Treating Patients With Metastatic Melanoma
Start Date: February 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00871481

Study of Immunotherapy to Treat Advanced Prostate Cancer
Start Date: May 2009
Estimated Study Completion Date: December 2012
Estimated Enrollment: 800
ClinicalTrials.gov Identifier: NCT00861614

Further study details as provided by Bristol-Myers Squibb:

These are all trials that were started after the halting of the compassionate Use. Bristol-Meyer Squibb thinks we the Melanoma Patients are expendable so they continued there quest to seek out new uses for the Drug.

Get a bigger bang for the buck.

They already know it works well with Melanoma, so why not find other uses.

Base on my calculation, 923 late stage Melanoma Patients were denied the drug while Bristol–Meyer Squibb continued to apply and start up new trials.

Bristol-Meyer Squibb Quote:

“What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”

All Lip Service!!!!!!

“Jim, thank you so much for your efforts. My father passed away this past March. He was also scheduled to start the ipi trial last year and found out the Saturday before he was to go in that the compassionate use trial was suspended. He developed 3 mets in his brain by Thanksgiving. The ipi trials with brain mets were closed to new patients by then. I've spent countless hours and days frustrated and angry, unable to express or figure out what you have with BMS and wanting to take some sort of action. I also sent letters, made phone calls, etc. One day, someone will be able to stop these drug companies from playing with our lives. Please keep me posted in your findings.”

Update on Ipilimumab

Ipilimumab is not back yet. Patients are not being encouraged to wait for Ipilimumab to become available for now. The only Ipilimumab melanoma trials currently enrolling new patients in the US are the brain metastases trial (CA-184042) and the phase 3 adjuvant trial (CA-184029) because the supply for those trials was protected in advance. Bristol Myers Squibb is working diligently to overcome the drug shortage, but can’t guarantee a time that it will return to the compassionate use setting.

Source: Melanoma International Foundation:

Melanoma International Foundation

Response from BMS as of 10-21-2009

“Regarding compassionate use, as you are aware, the rate of enrollment in the compassionate use program for ipilimumab was greater than anticipated with 30 to 40 percent of patients continuing on therapy beyond the initial induction schedule. This demand depleted drug supply at a faster rate than anticipated. Bristol-Myers Squibb had to suspend enrollment of new patients into the compassionate use program and single patient exemptions to ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide supply for ongoing clinical studies.

We are working through the manufacturing and testing process, and continue to carefully manage the supply to enable the potential re-opening of compassionate use at the earliest possible time and when continuous supply is available.

Bristol-Myers Squibb remains committed to the development of ipilimumab and to addressing the great unmet medical need for patients with metastatic melanoma.”

As you can read, BMS is not even acknowledging that they even produced other batches.They are hiding the fact that they are back online. Their communication skills with the public/patients are NIL. Instead they are starting new protocols with Ipilimumab. Where is the FDA in al of this? Who is watching the hen house?

When I searched for drug shortages on the FDA website, Ipilimumab did not show up.

What is going on?

We the Patients deserve better, We are the ones who are taking all the risk. We should have some control in this process.

We the Patients have had to hear it from second-hand sources like the Melanoma International Foundation and Melanoma Research Foundation. I don’t believe that their ad advertisers (The Ogilvy Group Inc) can repair the public’s trust in this company. They have major issues.

This Month will be the anniversary of the discovery of Anti-CTLA-4 antibodies, celebrating ten years in the making of the drug. This is way to long for a drug to come to market. It usually takes 8.7 years for monoclonal antibodies. So what gives?

I hope see some dialog started between the patients and BMS. BMS needs somehow to regain the public's trust.

I am under the impression that greed and power-play is mixed in all of this. It all has to do with the STRING OF PEARLS intiative.

How Drugs are Developed and Approved by the FDA?


How Drugs are Developed and Approved by the FDA

Take Care,

Jimmy B

Saturday, October 17, 2009

Hope!! Yes we Can!! Melanoma..Jim Breitfeller

Message of HOPE from Karen Velasquez 10/2009

Turn off Music before playing


Take Care,

Jimmy B

Friday, October 16, 2009

Main roads to melanoma..Jim Breitfeller

Main roads to melanoma

This paper is very technical but gives great insight into Melanoma and the pathways that are associated with it. It is quite long and should be read in small bites. Please don't be intimidated by it.

Giuseppe Palmieri1, MariaElena Capone2, MariaLibera Ascierto2, Giusy Gentilcore2, David F. Stroncek3, Milena Casula1, MariaCristina Sini1, Marco Palla2, Nicola Mozzillo2, and Paolo A. Ascierto*2


The characterization of the molecular mechanisms involved in development and progression of melanoma could be helpful to identify the molecular profiles underying aggressiveness, clinical behavior, and response to therapy as well as to better classify the subsets of melanoma patients with different prognosis and/or clinical outcome. Actually, some aspects
regarding the main molecular changes responsible for the onset as well asthe progression of melanoma toward a more aggressive phenotype have been described. Genes and molecules which control either cell proliferation, apoptosis, or cell senescence have been implicated. Here we provided an overview of the main molecular changes underlying thepathogenesis of melanoma. All evidence clearly indicates the existence of a complex molecular machinery that provides checks and balances in normal melanocytes. Progression from normal melanocytes to malignant metastatic cells in melanoma patients is the result of a combination of downor up-regulation of various effectors acting on different molecular pathways.


Main Roads to Melanoma

Take Care,

Jimmy B

Thursday, October 15, 2009

The Top 5 Most Promising Upcoming Drugs for Melanoma..Jim Breitfeller

New Phase III Clinical Trials for the Treatment of Melanoma
From Timothy DiChiara, Ph.D., for About.com
Created: May 21, 2009

About.com Health's Disease and Condition content is reviewed by the Medical Review Board

Treatment of advanced (stage III and IV) melanoma is in desperate need of some good news. Although the incidence of melanoma is increasing by a whopping 3 to 5% per year in the United States, current therapies don't significantly increase survival in most patients and no new first-line medicines have been approved in over 10 years.
Clinical trials are the best hope for a long-lasting reduction or elimination of metastatic melanoma (called a "durable response" or "complete response" by doctors). The US National Institutes of Health lists 27 late-stage (phase III) clinical trials currently recruiting patients with melanoma. Many of the trials are testing new combinations of existing drugs, new ways to administer them, or new surgical procedures, but some are investigating brand new drugs. The most promising are the following:

Allovectin-7 - This novel gene therapy is injected directly into the tumors of patients with stage III or IV disease, which then alerts the body's own immune system to attack the tumor. Earlier trials of Allovectin alone showed that tumors in 4% to 9% of patients responded to the therapy. The new trial is comparing Allovectin-7 to the standard chemotherapy treatment, either dacarbazine or temzolomide. Made by Vical. Find out if you may qualify for the AIMM trial of Allovectin-7.

oblimersen (Genasense) - Genasense is a unique inhibitor of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death (called "apoptosis"). So by reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Previous studies demonstrated that Genasense combined with the chemotherapy drug dacarbazine tripled response rate and significantly increased overall survival compared to dacarbazine alone. Made by Genta. Find out more about the AGENDA trial of oblimersen.

MVax - MVax is a melanoma vaccine prepared from the patient's own cancer cells. Several studies have shown that MVax followed by interleukin-2 can lead to a complete response in up to 13% of patients, double that of interleukin-2 alone. MVax is also effective in patients with stage III melanoma when given post-surgery: it doubled the 5-year survival rate compared to surgery alone. Made by AVAX Technologies. Find out more about the MVALDI trial for MVax.

ipilimumab (MDX-010, MDX-101, or BMS-734016) - Ipilimumab is an antibody that activates the body's immune system to fight melanoma by inhibiting the CTLA-4 molecule. Three previous phase II clinical trials have shown that treatment with ipilimumab results in a one-year survival rate of 47% to 51% for people with stage III or IV melanoma, which is almost double the average. The current trial is comparing ipilimumab to a dummy treatment (placebo) in patients with stage III melanoma who have already undergone surgery. Made by Medarex and Bristol-Myers Squibb. Find out more about the EORTC 18071 trial for ipilimumab.

OncoVEXGM-CSF - OncoVEXGM-CSF is a vaccine that works by spreading within tumors and causing the death of cancer cells while stimulating the immune system to destroy metastatic tumors. Previous results from 50 patients with inoperable stage IIIc/IV melanoma demonstrated that 28% of patients responded, including 12% with a complete response. The new trial is enrolling patients with previously treated but inoperable stage IIIb, IIIc or IV melanoma and is designed to compare OncoVEXGM-CSF to a naturally-occurring substance in the body called a "granulocyte monocyte colony stimulating factor" (GM-CSF), which increases white blood cells. Made by BioVex. Find out more about the trial for OncoVEXGM-CSF.

Why Participate in Clinical Trials

Those who take part in clinical trials get access to the latest treatments that are often not available anywhere else. These treatments may be better than the standard of care and may offer the only hope for those with advanced disease. Simply put, participation in clinical trials by patients like you is the only way research will advance toward an eventual cure for melanoma.

Talk about the possibilities with your doctor!


ClinicalTrials.gov. US National Institutes of Health. 10 February 2009.

Take Care,

Jimmy B
Take Care,

Jimmy B

Friday, October 2, 2009

This is why I am so upset.Melanoma..Jim Breitfeller

COPosted by Tim--MRF at 02:47 on Mon, Sep 28, 2009 [Show other posts by Tim--MRF](Melanoma Research Foundation)

In Reply to: Bristol-Meyer Squibb has a lot to Explain!! Ipilimumab compassionate use by Jim Breitfeller posted at 08:03 on Mon, Sep 28, 2009


I have had the opportunity to meet with several people at BMS who are involved in ipi and can tell you that they share your frustration. The official word is that when they applied for compassionate use approval they underestimated the demand they would face. That plus the fact that people were surviving longer on the drug placed an unanticipated strain on capacity, resulting in suspending the compassionate use program. They have a new batch of ipi available, but are holding off on compassionate use until they are absolutely sure they have enough to fulfill the requirements of the clinical trials. I have heard that the trials are largely enrolled and that many trials have waiting lists. I have sent a note to the people I met at BMS and asked them two questions you raise: Why did the new batch take so long? And, when do they expect compassionate use to be re-opened? The word I had earlier was the first quarter of 2010. I will post again when and if I get a reply.

I have tried to encourage them to provide regular updates on status--people definitely want to know what is going on.


So why is the compassionate Use not first inline to get it?

It comes down to greed.They are looking after their bottom line but they preach:

What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”

All Lip Service!!!!!





Take Care,

Jimmy B

A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells.Melanoma ..Jim Breitfeller

A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells. Patients with advanced hormone refractory prostate cancer who have failed to respond to chemotherapy may qualify for this unique clinical trial.

Canton, Ohio (PRWEB) October 2, 2009 -- A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells. Patients with advanced hormone refractory prostate cancer who have failed to respond to chemotherapy currently have no viable options available. There is an experimental agent which is a monoclonal antibody that attacks the T-lymphocytes. Those lymphocytes' function is to weaken the immune system. By reducing the number of T-lymphocytes, the patient's immune system is augmented and strenthened producing antibodies that would potentially attack cancer cells.

A nationwide, placebo-controlled, clinical trial was recently launched where patients with prostate cancer who have received chemotherapy before will be treated with this monoclonal antibody. Preliminary previous trials using this compound in patients with melanoma and other cancers have produced encouraging results that made investigators conduct this large, clinical trial for prostate cancer patients.

Researchers involved in this innovative and relatively safe treatment (including Gabrail Cancer Center, Canton, Ohio) are trying to find out if this agent will produce an additional weapon to fight prostate cancer especially since there are no alternative therapies available. Log on to www.GabrailCancerCenter.com or call (330) 492-3345, for more information


Bristol-Meyer Squibb closed the compassionate drug use of Ipilimumab so it could open NEW CLINICAL TRIALS FOR OTHER CANCERS!

Do you see the Disparity in that?

This so unethical it makes me SICK.

Bristol-Meyer Squibb should reopen the Compassionate Use NOW!!!!!!!

The FDA should also look into the supposedly shortage that Bristol-Meyer Squibb CREATED so it could open NEW CLINICAL TRIALS OF OTHER CANCERS.

Take Care,

Jimmy B

Thursday, October 1, 2009

Jimmy B. about your last post 8-4-2009 ..Timing and Tregs.Melanoma.Jim Breitfeller

Jimmy B. about your last post

Posted by JerryfromFauq at 12:02 on Tue, Aug 04, 2009 [Show other posts by JerryfromFauq]
I copied it and emailed your last post here to my Medical Oncologist at UVA. Below is his response. Keep up the good work.
Dear Mr. Ellis,
Thanks for this information. The impact of IL-2 on regulatory T-cells has long been known from animal studies. I am very interested to see this approach to the phenomenon and the proposal to regulate regulatory T-cell action. As you know, antibodies now exist which inhibit regulatory T-cell activity (ipilimumab and tremilimumab).

I think this timing approach has merit.
Thanks again.

Weiss, Geoffrey R
From: tjellis [mailto:tjellis]
Sent: Saturday, August 01, 2009 7:14 PM

To: Weiss, Geoffrey ,
Subject: IL-2 administration increases CD4 + CD25(hi) Foxp3+ regulatory T cells in cancer

The following post was provided by a medical researcher that has Melanoma and posts on the MPIP.org.

He has some interesting theories from his research and experience about the timing of treatments that is posted on his website.
IL-2 administration increases CD4 + CD25(hi) Foxp3+ regulatory T cells in cancer

Take Care,

Jimmy B

Am I seeing Double?? Melanoma..Jim Breitfeller

I was able to get in touch Dr.Bucay the Dermatologist that went through therapy. She gave me her timeslines so I graphed it.


I guess the main take away is "There is Hope". Two complete responses doesn't make a cure. We used two different monoclonal antibodies with two different regimens - (medicine) a systematic plan for therapy (often including diet). It is interesting to note that the time between therapies are very close.

The overall time difference my be due to the fact that we had different tumor loads.

My bet is on the timing!!!

Take Care,

Jimmy B

Surviving Advanced Melanoma..A DERMATOLOGIST'S PERSONAL PERSPECTIVE.Melanoma.Jim Breitfeller

Vivian W. Bucay, MD
Clinical Assistant Professor
Dept of Physician Assistant Studies
University of Texas Health Science Center - San Antonio, TX

"As a dermatologist in clinical practice since 1991, I have had many opportunities to make a positive impact on patients' lives by being the first to diagnose and treat skin cancers, above all nonmelanoma skin cancers. Fortunately, almost every patient has had a good outcome, primarily because of early diagnosis and intervention. Like most dermatologists, I understand that if I encounter high-risk melanoma or advanced disease, clinical management will most often become the responsibility of surgical and medical oncologists, while I will navigate shallower waters, such as screening family members and reviewing pertinent but often confusing literature to assist the patient and family in making important decisions regarding treatment.

I have gained quite a new perspective on melanoma, however, since becoming an advanced melanoma patient myself in 2006. I have previously chronicled my personal battle with the disease twice before, first in San Antonio Medicine, a publication of the Bexar County Medical Society, in an issue dedicated to the physician as patient,1 and second, in the 2008 Skin Cancer Foundation Journal, a publication targeted to the lay public.2

My purpose in this issue of The Melanoma Letter is twofold: to present treatment options for Stage III and Stage IV melanoma in the manner in which they became relevant for me, and to emphasize that good outcomes are not only possible, but becoming more attainable every day despite seemingly unfavorable odds.

On May 5, 2006, I asked my physician assistant (PA) to look inside my umbilicus to see whether or not she noticed anything unusual; I had noticed a white "residue" that appeared on dark clothing. There was no itching, bleeding, or tenderness, just a whitish discharge that had appeared intermittently for the previous few weeks. I had no recollection of any existing abnormality in the region, keeping in mind that I had seen my umbilicus at its peak convexity during each of my three pregnancies. Nonetheless, as I mentally reviewed the differential diagnosis — psoriasis, eczema, seborrheic dermatitis — melanoma was not on the list while I was undergoing a routine shave biopsy; my PA chose to do the biopsy for safety's sake despite noting nothing unusual herself.

So we were both surprised when we received the diagnosis by phone on May 10 from the dermatopathologist to whom I routinely send my patients' biopsies: amelanotic malignant melanoma, possibly metastatic. I suspected (or hoped) that it was a false positive produced by using a shave specimen rather than a full excisional biopsy. However, there was no error in the diagnosis, as immunohistochemistry proved positive for S-100, HMB-45, and MART-1."

The rest can be found at Surviving Advanced Melanoma..A DERMATOLOGIST'S PERSONAL PERSPECTIVE

I am amazed how similar my treatment and Dr. Bucay's was, and how we had the same outcome NED. This reinforces my scientific theory on the combination of the two treatments.

I am in the process of trying to get in touch So we can compare time lines.

Take Care,

Jimmy B

Greetings to One and All

This Blog is dedicated My Brother Kenny B. who passed away in the late 1970's with Cancer before the Internet.

It was he, who showed me How to live and give back. He was wise beyond his years.

Kenny B

Jimmy and Dee

Carepage: Jimmybreitfeller
Jimmy Breitfeller

My Profile as of 2009

My photo
Last July (2005)I was riding my bicycle to work at the Eastman Kodak Research Labs about 3 miles from home. I was wearing a knapsack to carry my things to and from the labs. I started noticing an ache on my back. So I decide to go to the dermatologist. To make the long story short, it was cancer. I knew from my research that I would be needing adjuvant therapy. So I started communicating with Sloan Kettering, University of Pittsburgh Cancer Center, and a couple of others including the Wilmot Cancer Center at Strong. I realized that by telling my story, I might help someone else out there in a similar situation. So to all who are linked by diagnosis or by relation to someone with melanoma, I wish you well. Stay positive, read as much as you can (information helps to eliminate the fear associated with the unknown), and live for today, as no one can predict what tomorrow may bring. Jimmy B. posted 12/15/08


The information contained within this Blog is not meant to replace the examination or advice of your Oncologist or Medical Team. The educational material that is covered here or Linked to, does not cover every detail of each disorder discussed.

Only your physician/Oncologist can make medical decisions and treatment plans that are appropriate for you. But, An Educated Consumer is a Smart consumer.

As Dr. Casey Culberson Said:

"The BEST melanoma patient is an ACTIVE PARTICIPANT in his or her treatment

Melanoma and the “Magic Bullet” (Monoclonal Antibodies)

Just to let you know I posted the first draft of the Melanoma and the “Magic Bullet” (Monoclonal Antibodies). on Melanoma Missionary In the Shared File Section. you can download it for 19.95 (Only kidding) it is Free for the taking.

It is 33 pages long and may help you in your quest for the Yellow Brick Broad. Just to let you know it is only the first draft. Revisions are sure to come. I wanted to get it to the people that need it the most, the Melanoma Patients.


So, where does Interluekin-2 (IL-2) come into play? According to Byung-Scok et al and recent reports, IL-2 is not needed for developmental CD4+ CD25+ Treg cells in the thymus but does play an important role in the maintenance and function in the peripheral.18 Peripheral is defines as secondary system outside the bone marrow and thymus. It entails the site of antigen, immune system interaction. IL-2 is required for the peripheral generation of Tregs based Abbas’s and colleagues research.19

IL-2 prevents the spontaneous apoptosis of the CD4+ CD25+ Treg cells. It has been reported that patients with multiple advance-stage tumors have elevated levels of Tregs within the tumor microenviroment.20 Interluekin-2 is the survival factor for CD4+ CD25+ Treg cells.21 If the addition of IL-2 is on or before the maximum propagation of the CD4+ T cells, the Tregs population can increase 5-fold in a 96 hour period based on certain growth mediums.

By controlling the addition of the endogenous IL-2, one has a knob to turn and can lead to the control of the expansion of the Tregs. When you combined this control with the anti-CTLA-4 blockage, you can shift the balance of the immune response.

Now here is the catch. The maintenance and function of the CD8+ T-cells require CD4+ cells which secrete IL-2. So we don’t want to deplete the CD4+ cells, we want to control the expansion of the Tregs which are a subset of the CD4+ cells. It has been postulated by some researchers that the Anti-CTLA-4 blockage also suppresses the Treg function in a different mechanism. By using IL-2 as the rate limiting factor, we can suppress the CD4+ CD25+ Treg cell expansion by controlling the concentration and timing of the Inerluekin-2 at the tumor microenvironment.

The Interluekin-2 plays another role in this Melanoma Maze. In a study by Janas et al, Il-2 increases the expressions of the perforin and granzyme A, B and C genes in the CD8+ T-cells. This increase expression causes the CD8+ T-cells to mature into Cytoxic T Lymphocytes (CTLs). The exogenous IL-2 is required for the granzyme proteins. As stated previously, CTLs have cytoplasmic granules that contain the proteins perforin and granzymes. A dozen or more perforin molecules insert themselves into the plasma membrane of target cells forming a pore that enables granzymes to enter the cell. Once in the tumor cell, these enzymes are able to breakup (lyse) the cell and destroy it. This is the beginning of the end for the cancer cells. The tumors begin to shrink and the rest is history,

On the other hand, prolong therapy with Il-2 can result in causing apoptotic death of the tumor- specific CD8+ T-cells.23

Clearly in a clinical setting, timing, dose, and exposure to these drugs play a major roll in the immunotherapy, and can have dramatic effects on the outcome.

All it takes is that one magic bullet to start the immune reaction..


Melanoma And The Magic Bullet (Monoclonal Antibodies)

Public Service Announcement

A call for Melanoma Patients by Dr. Steven A Rosenberg

"We continue to see a high rate of clinical responses in our cell transfer immunotherapy treatments for patients with metastatic melanoma", Dr. Rosenberg said.

"We are actively seeking patients for these trials and any note of that on a patient-directed web site would be appreciated."

If you would like to apply for his trials, here is the website and information.

Dr. Rosenberg's information

Dr. Rosenberg's Clinical Trials

For the Warriors

The Melanoma Research Alliance has partnered with Bruce Springsteen, the E Street Band, and the Federici family to alleviate suffering and death from melanoma. Please view Bruce Springsteen’s public service announcement inspired by Danny Federici. Danny was the E Street Band’s organist and keyboard player. He died on April 17, 2008 at Memorial Sloan-Kettering Cancer Center in New York City after a three year battle with melanoma.


Source Fastcures blog

Join the Relay for Life!!!


Dear Family and Friends,

I’ve decided to take a stand and fight back against cancer by participating in the American Cancer Society Relay For Life® event right here in my community! Please support me in this important cause by making a secure, tax-deductible donation online using the link below.

To donate on line now, click here to visit my personal page.
Jimmy B AKA Melanoma_Missionary

Relay For Life® is a life-changing event that brings together more than 3.5 million people worldwide to:

CELEBRATE the lives of those who have battled cancer. The strength of survivors inspires others to continue to fight.

REMEMBER loved ones lost to the disease. At Relay, people who have walked alongside people battling cancer can grieve and find healing.

FIGHT BACK. We Relay because we have been touched by cancer and desperately want to put an end to the disease.

Whatever you can give will help - it all adds up! I greatly appreciate your support and will keep you posted on my progress.

Keep the Fire Burning!!!



Jimmy Breitfeller
Turn off Music before you "Click to Play"
Signs of Melanoma Carcinoma Skin Cancer

How Skin Cancer Develops by "About.com : Dermatology"

Call for Patients with Unresectable Liver Metastases Due to Melanoma

Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma

Delcath is actively enrolling patients in a Phase III clinical trial testing its proprietary drug delivery system, known as Percutaneous Hepatic Perfusion (“PHP”), with melphalan for the treatment of ocular and cutaneous melanoma metastatic to the liver.

This NCI-led trial is enrolling patients at leading cancer centers throughout the United States. Commenting on these orphan-drug designations, Richard L. Taney, President and CEO of Delcath, stated, “These favorable designations are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our pivotal Phase III trial for metastatic melanoma. We remain steadfast in our commitment to become the leader in the regional treatment of liver cancers and we continue to enroll patients in this study, and advance our technology and the promise that it offers to patients with these deadly forms of melanoma and other cancers of the liver, all with limited treatment options.”

Orphan drug designation, when granted by the FDA’s Office of Orphan Products Development, allows for up to seven years of market exclusivity upon FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.

Current Trial Centers

Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemofiltration Using
Percutaneously Placed Catheters in Patients With Unresectable Hepatic Malignancies

James F. Pingpank, Jr., MD, FACS
Associate Professor of Surgery
Division of Surgical Oncology
Suite 406, UPMC Cancer Pavillion
5150 Centre Avenue
Pittsburgh, PA 15232
412-692-2852 (Office)
412-692-2520 (Fax)

Blog Archive

Call For Melanoma Patients!!!!

Call For Melanoma Patients!!!!

Dr. Rosenberg Has a New Clinical Trial.

Our latest treatment has a 72% objective response rate with 36% complete responses.

We are currently recruiting patients for our latest trial.

Is there some way to post this “Call for Patients” on the web site?

Steve Rosenberg

Dr. Rosenberg's Clinical Trials

(For a copy of the research paper.. see My Shared files)

The news headlines shown above for Melanoma / Skin Cancer are provided courtesy of Medical News Today.