Goshen Doctor on Time's 100 List.. Melanoma ..Jim Breitfeller

Goshen Doctor on Time's 100 List

TIME Magazine announced that Dr. Doug Schwartzentruber, Medical Director of Goshen Health System's Goshen Center for Cancer Care, has been named to the 2010 TIME 100, the magazine's annual list of the 100 most influential people in the world

He is being recognized for the strides he and Goshen Center for Cancer Care are making in cancer research.


"One of the first studies to prove vaccines might have a medical benefit against cancer, Schwartzentruber's study results found the new therapeutic cancer vaccine, given in combination with an existing melanoma treatment called Interleukin-2, doubled the response rate for tumor shrinkage as well as delayed the progression of cancer in patients with metastatic melanoma."

Source:http://www.insideindianabusiness.com/newsitem.asp?ID=41419

Goshen Doctor on Time's 100 List 2010


The reason I am brining this to your attention is that I have wrote to
Dr. Schwartzentruber.

The timing of the addition of IL-2 to the vaccine is crucial to the response outcome.

Just think what could be accomplished if Dr.Schwartzentruber timed the addition of the IL-2.



The Making of an Immune Response by Combinatorial Therapy Using Anti-CTLA-4 Blockade and Interleukin-2





Take Care,

Jimmy B

Melanoma: A model for testing new agents in combination therapies..Jim Breitfeller

Melanoma: A model for testing new agents in combination therapies

Email to Dr. Mario Sznol 4-27-2010

Dr. Sznol,



I just read your paper on test new agents in combination therapies. I would like you to take a look at a combination that I did as a stage IV Melanoma Patient under the care of Dr. John M. Kirkwood.

Melanoma: A model for testing new agents in combination therapies



It involves interferon alpha, DTIC + Patrin-2 , Anti-CTLA-4 blockade and HD interleukin-2. By doing these drugs in a systematic way, I was able to eradicate 40+ nodules in my lungs and others in the subcutaneous area of my back. Dr. Kirkwood thought I was a one off. Based on my 25 yrs. in the Kodak research labs as an analytical chemist, I was able to research why my treatment worked.


I would like to present it to you so you can expand on the knowledge and put it to practice.


Please don’t let it fall on deaf ears. We the patients need your help to think outside the box and push the Melanoma research to new frontiers.



Melanoma and The Magic Bullet (Monoclonal Antibodies)





Take Care,

Jimmy B

Faltering Cancer Trials Melanoma.. Jim Breitfeller

Faltering Cancer Trials
Editorial
Published: April 24, 2010


The government’s system for judging the clinical effectiveness of cancer treatments, recently found to be in “a state of crisis,” must be repaired.

Here is a recent article from the New York Times. Thanks to Ed a carepage friend and colleage for bringing this to my attention.


Source:http://www.nytimes.com/2010/04/25/opinion/25sun1.html

Faltering Cancer Trials



We need the Patients to unite and get the best therapy for their condition. This is not rocket science, it is biochemistry at it's best. We need Big Pharma(Bristol Myer Sqiubb, Novartis,Pfizer, Plexikkon, Hoffman La Roche and others) to step up to the plate and do what is ethical. Not just looking at their bottom line. Without patients/consumers, these drug companies would not exist.

Our future survival is in our hands. The cure is out there. We need the medical community to take notice.




Take Care,
Jimmy B

MELANOMA: A COMBINATION THERAPY - SALUTE DOMANI ∞ IL PORTALE DEL BENESSERE..Jim Breitfeller

MELANOMA: A COMBINATION THERAPY - SALUTE DOMANI ∞ IL PORTALE DEL BENESSERE

Take Care,

Jimmy B

My CT scans have been Approved!! Melanoma ..Jim Breitfeller

My CT scans have been Approved!!
Posted 1 minute ago
My CT scans have been Approved!!!
The scans are scheduled for April 30th. 7:30 am.

I won't be able to release the data because it may Skew the ASCO data that will be released in June at the ASCO Annual Meeting.

God forbid we get the data early so that we, the patients, can make corrections to our path forward.

This is a Joke. ASCO holds back on data results until the start of their meeting and talks.

Why does ASCO embargo Clinical data that is positve before their annual Meeting? Melanoma The patients deserve better. Shame on ASCO!!!

Bristol-Myers Squibb announced the following pipeline highlights:
The company has data from its first phase 3 study (MDX-020) of ipilimumab, which had a primary endpoint of overall survival and was conducted in patients with previously-treated melanoma. Ipilimumab is a novel immuno-oncology compound in late-stage development.

The company has submitted study results for scientific presentation at the American Society of Clinical Oncology (ASCO) annual meeting in June. Management said it is in discussions with health authorities worldwide in planning for submitting biologics licensing applications (BLA) in this patient population.

The company also has data from a randomized phase 2 study of ipilimumab in non-small cell lung cancer that it also has submitted for presentation at ASCO this year. As a result of the study, the company is moving forward with a phase 3 study of ipilimumab in this indication.


Take Care,

Jimmy B

Major Overhaul of NCI-Funded Cancer Trials Network Urged..Melanoma .Jim Breitfeller

Major Overhaul of NCI-Funded Cancer Trials Network Urged
By Alicia Ault
Elsevier Global Medical News
Breaking News
April 15, 2010 11:34 AM EDT

Saying that the cancer clinical trials system is in a state of crisis, an expert panel of the Institute of Medicine (IOM) called for an overhaul to speed up trial design and execution, incorporate scientific discoveries more rapidly, and create a structure to reimburse physicians and cover patients’ costs for participation in studies.

In a report issued Apr. 15, the 17-member panel said the backbone of the system, the National Cancer Institute-supported Clinical Trials Cooperative Group Program, has become cumbersome and inefficient. According to the report, it takes an average two years to design, approve, and start a trial. Only half of trials are ever completed. And, while knowledge is exponentially increasing, the groups’ funding has decreased by 20% over the last 8 years.

Moreover, enrollment in trials is abysmal. The American Cancer Society estimates that only 5% of adults with cancer participate.

“Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point,” said the IOM panel’s chairman, Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston.

“The program urgently needs changes across the board, if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means,” he said.

The American Society of Clinical Oncologists (ASCO) applauded the IOM panel’s recommendations. “The Cooperative Clinical Research Program is the jewel in our nation’s cancer research system, and is critical to advancing progress against the disease,” said Dr. Richard L. Schilsky, immediate past president of ASCO, in a statement.

The Cooperative Group Program, which is supported by the National Cancer Institute (NCI), comprises 10 groups that incorporate 3,100 institutions and 14,000 investigators. Some 25,000 patients participate in cooperative trials each year.

The IOM says that the groups have made important contributions over the half-century they have been in existence. For instance, largely as a result of findings from cooperative trials, pediatric cancer survival rates rose from 10% in the 1950s to 80% now, said the report.

Because the program does have the potential to be more efficient and effective, “it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI’s translational continuum,” wrote the panelists in the report.

It will be an uphill battle. Currently, funding for the groups makes up only 3% of the NCI’s budget.

Dr. Schilsky said that “the system is being starved of funding.” In real dollars, “the program receives less funding today than it did a decade ago,” he noted.

“ASCO calls on NCI to double its support for cooperative clinical research within five years,” said Dr. Schilsky, a professor of medicine and section chief, hematology/oncology at the University of Chicago Medical Center, who also served on the panel.

The IOM panel called for increased funding, but also urged changes that could be made without new money. It recommended an evaluation of the necessity and contributions of each group, and a shift by the NCI from oversight to pure facilitation of trials. The groups need to move beyond cooperation to “integration,” said the report. That would include a consolidation of some front office and back office operations of the groups and improved collaboration among all the stakeholders.

The ability to recruit, train, and retain enough clinical investigators is also crucial to the rebuilding of the trial system, said the IOM panel. It recommended that health insurers, Medicare, and federal and state health programs cooperate to establish consistent payment policies to cover all patient care costs in a trial, except for the drugs, devices, or diagnostics, which should continue to be paid for by the manufacturers.

Such policies might act as an incentive for patients to participate in trials, said the panel.

The experts also urged the American Medical Association to create new current procedural terminology (CPT) codes that would create a payment pathway for offering, enrolling, managing, and following a patient through a clinical trial. The new codes would reflect the additional time that physicians put in to getting patients into a trial, and for managing potential adverse events.

And, they would likely be a powerful incentive for physicians to consider putting more of their patients in studies, said the panel.

Physicians, indeed, are not happy about reimbursement. An ASCO survey released Apr. 15 showed that one-third of Cooperative Group Sites said they planned to limit participation in those trials due to inadequate per-case reimbursement. Almost 40% of those who were going to limit cooperative studies said they would instead increase their participation in industry-sponsored trials.

Source:http://egmn.idsk.com/stories_us/16_ds_11270391.jsp



Take Care,

Jimmy B

Applying Dosing Schedules to the Protocols of Combo Therapy, Optimize the clinical outcome 4-14-2010 Note to Rosenberg Melanoma Jim Breitfeller

Applying dosing schedules to the clinical protocols of combinatorial therapy, we can optimize the clinical outcome 4-14-2010 Note to Dr. Rosenberg
In 1986, a clinical protocol for the treatment of advanced malignant melanoma with
the newly discovered class of immune cells called TIL was initiated at the National Institutes of Health (NIH). These lymphocytes are T cells that are isolated directly from the tumor and that are then grown to large numbers in tissue culture in the presence of the T cell growth factor interleukin-2 (IL2). After expansion in culture several thousand times, approximately 2 X 10" TIL are given to the patient intravenously in addition to high doses of IL-2 in several days of treatment. Even in those patients who did not respond to all other therapy (including treatment with IL-2 alone), 35 to 40% of patients responded to this protocol.

The large-scale tissue culture and the large numbers of cells and IL-2 that are given to a patient make this procedure expensive and clinically difficult. Furthermore, 60 to 65% of patients fail to respond to this treatment, and even those who do respond will often fail after 6 to 12 months. It is likely that only a subset of the heterologous population of cells administered to a patient are effective in killing cancer cells in vivo.

That was then (1986) and this is now 2009. Dr. Rosenberg and colleagues have optimized the protocol to generate a response rate of 72% using lymphodepletion prior to Adaptive Cell Therapy.

It cannot be certain that the TIL subsets preferentially recovered from the tumor biopsy corresponded to those that mediated complete elimination of tumor in this patient.

Recently, a patient that went down to NIH and did the ACT therapy had a response only where the cells came from (lungs). The other tumors continued to progress.

Are the TILs tumor specific based on where the cells were obtained during biopsy? Does this mean the other tumors mutated or are they missing some receptor or MHC I or II at the tumor surface?


Adoptive Cell Transfer.. 57 days after transfer. CD8+ T-cell (CTLs) at the Maximum Propagation


A tumor lesion excised from patient 9 before nonmyeloablating chemotherapy ("pretreatment") exhibited scant CD8+ cells (left), strong stromal cell staining but weak staining of tumor cells with antibody to MHC class I (center), and sporadic cell staining with an antibody to MHC class II (probably tumor macrophages) but minimal staining of tumor cells (right). In contrast, a sample resected 57 days after cell transfer ("post treatment") exhibited a dense, diffuse CD8+ infiltrate and ubiquitous expression of both MHC class I and class II molecules in tumor cells.

Source: Cancer Regression and Autoimmunity in Patients After Clonal Repopulation with Antitumor Lymphocytes
Originally published in Science Express on 19 September 2002
Science 25 October 2002:
Vol. 298. no. 5594, pp. 850 - 854
DOI: 10.1126/science.1076514


Patients undergoing Anti-CTLA-4 Blockadge. Week7 = Day 49 maximum ALC.. CD8+ T-cell (CTLs)

Source: Dr. Jedd Wolchok





What I am trying to show is the growth curves for the various T-cells subsets with data from in vivo to back up the above graphic. With that in mind, we now have a better understanding on the growth patterns of these cells. By applying dosing schedules to the clinical protocols of combinatorial therapy, we can optimize the clinical outcome

Take Care,

Jimmy B

'Cure' is found for skin cancer, claim scientists..Melanoma ..Jim Breitfeller

'Cure' is found for skin cancer, claim scientists

Scientists believe that they have found a cure for skin cancer.

Published: 12:25AM BST 11 Apr 2010

A vaccine being tested in the UK has helped been shown to help some patients fully recover from melanoma, even in its advanced stages.

It attacks tumour cells, leaving healthy cells undamaged and carries agents that boost the body's response to skin cancer.


Dr Howard Kaufman, of Chicago's Rush University Medical Centre, said: "Our study shows we may have a cure for some advanced melanoma patients and a drug which has real benefits for others.

"This will save thousands of lives a year."

Over the past 25 years, rates of melanoma in Britain have risen faster than any other common cancer and 2,000 die from the disease every year.

A study of 50 patients with advanced melanoma who had been given no more than nine months to live found that 16 per cent of them recovered completely with the vaccine. They have been disease-free for more than four years.

Another 28 per cent saw the size of their tumours more than halved.

It is hoped the licensing will be "fast-tracked" and it will be on the market within five years.

Melanoma is now the most common cancer in young adults aged 15 to 34, with 10,41 new cases diagnosed every year in the UK.

Source:http://www.telegraph.co.uk/health/healthnews/7576456/Cure-is-found-for-skin-cancer-claim-scientists.html

The Company’s lead product, OncoVEXGM-CSF is a first in class oncolytic vaccine. OncoVEXGM-CSF is currently being evaluated in a Phase 3 multi-national study in metastatic melanoma and a Phase 3 study in head and neck cancer is scheduled to commence in the second half of 2010. BioVex believes OncoVEXGM-CSF has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date.

The Company has recently also commenced clinical testing in the UK with its vaccine candidate for the prevention and potentially the treatment of genital herpes.

 

OncoVEX Trials

Check them out!!!!!
For more information about participating in OPTiM call 888-990-3399 or email OPTiM@oncovexgmcsf.com.


http://www.oncovexgmcsf.com/info.html
Local and Distant Immunity Induced by Intralesional Vaccination
with an Oncolytic Herpes Virus Encoding GM-CSF in Patients
with Stage IIIc and IV Melanoma

https://www.box.net/shared/0uimdbqius

Take Care,

Jimmy B

Improve Survival from Advanced Melanoma..The Time Is Now!! Jim Breitfeller

"• Drug development efforts focusing on rare and understudied diseases such as
melanoma face unique challenges. Addressing the rising incidence and unique
biology of human melanoma will require a well-defined process to access and provide
input to existing NCI drug development programs such as the Cancer Therapy
Evaluation Program (CTEP) and the Rapid Access to Intervention Development
(RAID) program. The procedures followed by CTEP for identifying new agents for
evaluation and introducing them into clinical trials should be streamlined, and
interactions between CTEP and RAID should be expedited. Currently, the
Investigational Drug Steering Committee (IDSC) is designed to provide NCI with
broad external scientific and clinical input for the design and prioritization of phase I
and phase II trials with agents. IDSC membership has included principal
investigators, representatives from the NCI Cooperative Groups, NCI staff members,
and additional representatives as ad hoc members for consideration of specific agents.


• To facilitate rational clinical trials of therapies for advanced melanoma, researchers
need improved access to new drugs and orphan drugs. Testing of combinations of
drugs from multiple sources, including pharmaceutical companies and academia, will
accelerate progress in melanoma research. This is currently hindered by legal liability
and intellectual property issues. Regulatory support, and the additional funding
required, should be provided to facilitate access to promising drugs for preclinical and
clinical studies relevant to melanoma, even if their application is limited to this
disease, in order to address legal and IP issues. Drug companies should be
indemnified against the risks of allowing their drugs to be combined in innovative
strategies to encourage participation in melanoma clinical trials.

• Lost-opportunity drugs should be identified, and funds should be devoted to
production, validation, and quality control for drugs that private industry is unwilling
or unable to develop due to the perception that the market is limited. This is
particularly relevant when the investigational agent is not expected to have single
agent activity, but could be essential as an adjuvant to a vaccine or supplement one of
the important, existing immunologic approaches in melanoma.

• The melanoma research community needs dedicated support for the efficient study of
scientific opportunities within timelines expected in the more common tumors.
Funding for innovative new trials, especially those using agents from CTEP or
prepared by the RAID program, should be increased. This can be accomplished by
leveraging existing programs and creating partnerships.

• Biological discoveries in trials of patients with advanced disease may inform the
research in premalignant and early-stage disease, as well as predict which patients will
respond to immunologic therapies such as interleukin, interferon, T-cell antibodies, or
other signaling pathways. The government has a unique opportunity to stimulate
scientific research simultaneously with federally-supported treatment trials. Funding
should be designated for bench-to-bedside translational research through those clinical
trials that have the greatest potential to improve melanoma survival.
• A high-priority should be to enhance infrastructure that supports clinical trials in rare
diseases. Rare diseases require a focused national accrual effort for early drug
development trials in addition to large, randomized Phase III trials. Single-institution
funding is not sufficient to coordinate a national infrastructure. Existing structures
such as the NCI Cancer Trials Support Unit (CTSU) could provide regulatory
coordination and access on a national scale for Phase II trials, allowing the pace of
scientific inquiry to approach that of trials in common tumors."

Source: Final Melanoma Action Plan of 2007 NCI

Final Melanoma Action Plan of 2007 NCI


“You Can’t Start a Fire Without a Spark!!”

We need everyone to work together and drop the GREED.


Shared files





Take Care,

Jimmy B