Thursday, April 15, 2010

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.


Take Care,

Jimmy B

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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 " : 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.