Poised for progress..Melanoma ..Jim Breitfeller

Poised for progress
By Bill Schaller

Dana-Farber Cancer Institute

Friday, September 17, 2010

A new focus on the immune system’s ability to both unleash and restrain its attack on disease has led scientists at Harvard-affiliated Dana-Farber Cancer Institute to identify cells in mice that prevent the immune system from attacking the animals’ own cells, protecting them from autoimmune diseases such as multiple sclerosis, Type 1 diabetes, and lupus.

The discovery, recently reported by the journal Nature, may give scientists an effective way of operating the immune system’s internal “control panel,” leading to improved therapies for a variety of diseases — from vaccines that prompt the immune system to stage a sustained assault on cancers, to treatments that derail the biological onslaught associated with autoimmune diseases. The fact that human immune system cells share key features with those in mice makes the prospect of such advances quite realistic, the study authors say.

“The traditional view of the immune system is of specialized groups of cells poised to attack foreign pathogens [disease-causing agents],” said senior author Harvey Cantor, the Baruj Benacerraf Professor of Pathology at Harvard Medical School and chair of the Department of Cancer Immunology and AIDS at Dana-Farber. “While that model is generally correct, we’ve come to appreciate that the immune system, like other complex biological information systems, includes a counterbalance mechanism — a set of cells programmed to suppress the immune response. Such cells are essential to preventing excessive reactions to pathogens and misguided attacks on the body’s own cells.”

The search for cells involved in quieting the immune response has previously focused on immune system cells known as CD4+ T cells, some of which have been shown to prevent abnormal inflammation in response to disease or infection. In the new study, lead author Hye-Jung Kim and her colleagues found that CD8+ T cells (known as killer T cells because of their ability to kill diseased cells) also include a subset that helps dampen the immune response. Instead of reducing inflammation like their CD4 cousins, the CD8+ T regulatory (CD8+Treg) cells ensure that the immune system doesn’t produce antibodies that attack normal cells.

The Dana-Farber team discovered how CD8+ Treg cells accomplish this feat. They mingle with cells known as follicular T-helper cells, which are intermediaries that prompt the immune system’s B cells to make disease-fighting antibodies. The meeting with CD8+ Treg cells essentially shuts off the follicular T-helper cells, preventing them from interacting with B cells. No interaction means no production of antibodies, which means no assault on an animal’s normal, healthy cells.

The critical point of contact between CD8+ Treg cells and follicular T-helper cells is a protein on the helper cells called Qa-1. When Kim and her colleagues bred a strain of mouse with abnormal Qa-1, the animals developed a form of lupus. The reason: the CD8+ Treg cells couldn’t latch onto the defective protein, leaving the follicular cells free to order the B cells to produce antibodies, some of which targeted the animals’ own tissue.

The significance of this work is that CD8+ Treg cells represent a new lever for raising or lowering the strength of the immune response. This class of cells, it turns out, depends for its survival on a cytokine (a regulatory compound) called interleukin 15. Increase the supply of CD8+ Treg cells and the immune response is suppressed — a potentially powerful way of dealing with autoimmune diseases. Decrease the amount of such cells and the immune response can be invigorated and extended — a useful complement to vaccines that unleash the immune system on cancer.

“Experience has shown that vaccines that simply activate or expand the number of T and B cells are not likely to result in a prolonged, robust anti-tumor response,” Cantor explains. “The balancing mechanism within the immune system means that when more disease-fighting cells are generated, there’s a countervailing increase in the number of immune-suppressing cells that are generated. The key is to break that loop. This work brings that goal closer.”

Source:http://news.harvard.edu/gazette/story/2010/09/poised-for-progress/

A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
It is recruiting.

A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer

Maybe a combination of Anti-CTLA-4 blockage + IL-15 may be another protocol that will erradicate the Melanoma Tumor



“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”

~Charles Darwin~

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

Bristol Meyer Squibb, Where do you draw the Line in the Sand?Melanoma ..Jim Breitfeller

Bristol Meyer Squibb, Where do you draw the Line in the Sand?



“What I found over the next two and a half years of "researching the research" is a scandal in medical science that is at least the equivalent of any of the recent corporate scandals that have shaken Americans' confidence in the integrity of the corporate and financial worlds. Rigging medical studies, misrepresenting research results published in even the most influential medical journals, and withholding the findings of whole studies that don't come out in a sponsor's favor have all become the accepted norm in commercially sponsored medical research. To keep the lid sealed on this corruption of medical science—and to ensure its translation into medical practice—there is a complex web of corporate influence that includes disempowered regulatory agencies, commercially sponsored medical education, brilliant advertising, expensive public relations campaigns, and manipulation of free media coverage. And last, but not least, are the financial ties between many of the most trusted medical experts and the medical industry. These relationships bear a remarkable resemblance to the conflicts of interest the Securities and Exchange Commission recently brought to a halt after learning that securities analysts were receiving bonuses for writing reports that drove up stock prices with the intent of bringing in more investment banking business.”

Quoted from:

Overdosed America by John Abramson MD, page 9


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?

Where do you draw the Line in the Sand?

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:



Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer


Estimated Enrollment:30
Study Start Date:February 2009
Estimated Primary Completion Date:
February 2013 (Final data collection date for primary outcome measure)ClinicalTrials.gov Identifier:NCT00836407

A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (MDX-010) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer


Estimated Enrollment:36
Study Start Date:November 2009
Estimated Primary Completion Date:
November 2013 (Final data collection date for primary outcome measure)



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 as the STRING OF PEARLS.

.And the FDA has turned a blind Eye and gave it its unoffical approval to allow this to happen.
Where are the comsumers being protected. Without the patients, Bristol Meyer would have no trials. Very STRANGE BEDFELLOWS TO SAY THE LEAST.



Take Care,

Jimmy B

A Call for Patients for Dr. Rosenberg's Clinical Trials

"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






Take Care,

Jimmy B

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!

Source:

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

Take Care,

Jimmy B

Ah haaaaa!!!!!!!!! Road map to Recovery Melanoma..Jim Breitfeller

Follow the Yellow Brick Road!!!



"What we can learn from individual patients is often overlooked in oncology," he said, adding that many of these remarkable cases have led to the development of new treatment strategies for melanoma such as vaccinations against specific antigens and bone marrow transplantation. "From clinical observation, we can learn a lot from these remarkable cases."



Alan Houghton M.D., Chief of Immunology at Memorial Sloan-Kettering Cancer Center, New York





Well here are all the outside pieces to the Melanoma Puzzle. Now this may not work for every one but it did work so far for me. My last hurtle was how did my Immune system have the right antigen to present.



Without that piece of the puzzle, there would be no effective response.



Bobby Luker, this is for you and everyone who is still on the Yellow brick Road.







Take care



Jimmy B

Compassionate Drug Use for You and Me.. Melanoma..Jim Breitfeller

"Compassionate Drug Use

What is compassionate drug use?

Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available. Drugs that are being scientifically tested but have not yet been approved by the United States Food and Drug Administration are called investigational drugs. Access to one of these drugs when you are not in a clinical trial has many names, but is most commonly referred to as compassionate use.

Is compassionate drug use legal?

Compassionate drug use is legal, but it is tightly restricted to people who meet certain conditions. The FDA first approved investigational drugs to be used in this way for critically ill patients in 1987. There are 2 ways a drug company commonly gives access to their unapproved drug to a person who is not in a clinical trial:


expanded access program (EAP)
single patient access
A company sponsoring a drug in the late stages of drug development, including Phase III clinical trials, can offer expanded access programs for patients who are not able to enroll in a clinical trial. The FDA generally approves these programs if the drug has shown some effectiveness against a specific cancer in the clinical trials that are being done.

Patients who are not eligible for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access. In this case, the patient's doctor must first request permission for access to the drug from the drug company. If the company agrees, the patient's doctor works with the drug company to ask the FDA to approve the drug for use by this one patient. The length of time it takes to get single patient access varies. But if it is an emergency, the FDA can complete the paperwork in 24 hours.

Why are compassionate drugs used?

Compassionate drug use is mostly obtained for patients with advanced disease who have tried all of the available treatment options and whose disease has not responded, or for patients with diseases that have no approved treatment options and no clinical trials that meet the patients' needs. There must also be reason to expect some benefit from the investigational drug. In cases such as these, the doctor may consider trying to get a new, unapproved drug for a patient who is not in a clinical trial.

What problems are associated with compassionate drug use?

Perhaps the biggest problem with compassionate drug use is that it is hard to get. The simplest way to get access to an unapproved drug is through a clinical trial. But many people with life-threatening diseases either cannot find suitable clinical trials, or they live far from cancer research centers, or they are not eligible for any studies being done.

Expanded access programs (if offered by the drug company) or access through single-patient compassionate use is possible for some. But working out single-patient compassionate use of an unapproved drug is often time-consuming and frustrating. For instance, there is no single policy or process followed by the FDA and drug companies. As of 2007, no one publishes a list of all the drugs that are available through compassionate use in the United States. There is no way to require the drug company to supply the drug. Producing extra medicine for people who are not in clinical trials can be expensive for the drug company, especially since there is a chance the drug will not be approved.

Compassionate drug use can also be very confusing. There are several programs that regulate it. There are many terms and definitions that are used to describe how a patient may get access to an unapproved, new drug outside of a clinical trial. Drug companies, patient advocacy groups, and the FDA all may use different terms for the same things. For example, the terms used by the FDA are defined in their regulations, while most drug companies refer to their compassionate access programs with terms that are unique to their specific programs and not in line with the FDA language"

Source:http://www.cancer.org/docroot/ETO/content/ETO_1_2x_Compassionate_Drug_Use.asp

Compassionate Drug Use


Take Care

Jimmy B

Monoclonal antibodies primed to become potent immune weapons against cancer Melanoma ..Jim Breitfeller

March 20th, 2009

"New research suggests that monoclonal antibody therapy of cancer can be improved to be much more powerful than it is today, says a researcher at Georgetown University Medical Center's Lombardi Comprehensive Cancer Center in the March 21 issue of the Lancet.

"We believe that antibody therapy has the capacity to immunize people against cancer," says Louis Weiner, MD, director of the cancer center at GUMC and an internationally recognized expert in development and use of monoclonal antibodies. "Treatment modifications might be able to prolong, amplify, and shape a continuous immune response to cancer cells."

Weiner was asked by Lancet editors to write a review article discussing the newest research in this field. His co-authors are Madhav Dhodapkar, MD, of Yale University and Soldano Ferrone, MD, of the University of Pittsburgh.

Their analysis, based on reviewing the last eight years of research on monoclonal antibody treatment, suggests that a new era in use of these therapies is just around the corner. "Scientists have been able to use new tools to measure effectiveness of these therapies, and have found that antibodies are capable of stimulating the immune system in ways that had not been appreciated to date, and which we can now take advantage of," Weiner says.

Antibodies are immune system proteins that seek out and neutralize molecules they recognize as foreign to a body, such as viruses and bacteria. Monoclonal antibodies are proteins crafted in a laboratory to recognize specific receptors, or antigens, on cancer cells; some antigens promote uncontrolled growth. These antibodies are designed to both attach to cancer receptors to inhibit their function and to alert and activate the immune system to the presence of these receptor proteins.

Monoclonal antibodies already offer effective treatment for a wide range of cancers, including breast cancer (Herceptin®, Avastin®), colorectal cancer (Erbitux®, Avastin), lung cancer (Avastin), and blood cancers (Rituxan®, Campath®), but they have appeared to primarily work by forcing tumor related receptors to shut down pro-growth signals, Weiner says."


Source:http://www.physorg.com/news156772110.html


Take care

Jimmy B

Update on Federal and State Clinical Trials Legislation Melanoma .. Jim Breitfeller

ASCO continues its advocacy efforts at the federal and state levels to provide insurance coverage for the routine costs associated with patient participation in cancer clinical trials.

In Congress, Rep. Steve Israel (D-NY) has introduced the Access to Cancer Clinical Trials Act (HR 716)
. The legislation would require all health insurers – including those regulated by state insurance laws – to provide coverage for cancer clinical trials. Sen. Sherrod Brown (D-OH) introduced a companion bill in the Senate last year and is reportedly planning to do the same in this session of Congress.

Below is an update on five states that are considering legislation to require insurance companies to cover the routine patient care costs associated with clinical trials:

Colorado: On February 10, ASCO joined Rocky Mountain Oncology in sending a letter to Rep. Dianne Primavera in support of her bill (HB 09-1059) to require insurance companies to provide coverage to patients enrolled in all types of clinical trials. The legislation has passed a House Committee.

Nebraska: On February 13, ASCO and the Nebraska Oncology Society (NOS) sent a letter to State Sen. Mike Gloor, who is sponsoring legislation (LB 378) that would require insurance companies to provide coverage to patients enrolled in all types of clinical trials. ASCO and NOS also sent letters to members of the Senate Banking, Commerce, and Insurance Committee in support of the legislation, as the Committee held a hearing on February 17 on the legislation. ASCO also submitted written testimony in support of the bill.

Alaska: On February 18, ASCO President-Elect Douglas W. Blayney, MD, testified and ASCO submitted written testimony to a state Senate Health, Education and Social Services Committee hearing in support of legislation (SB 10) that would require insurers to provide coverage to patients participating in cancer clinical trials. ASCO is working with the Denali Oncology Group, ASCO’s affiliate society in Alaska, to support the legislation.

Iowa: ASCO also supports Iowa legislation (HSB 85 and SF 21) that would require insurers to provide coverage to patients enrolled in cancer clinical trials, and plans to work with the Iowa Oncology Society to support the legislation.

Kentucky: The House is considering legislation (HB 30) to require clinical trials coverage, and a companion bill has been introduced in the Senate (SB 102).

If these bills pass, these five states would join the 22 states and the District of Columbia that already have laws requiring clinical trials coverage. An additional three states have negotiated cooperative agreements with insurers to cover clinical trials. Information about these states is available on the NCI Web site
.

This is not a complete list of all the states that are considering clinical trials coverage legislation. If you are aware of clinical trials legislation under consideration in your state that is not listed here, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or researchpolicy@asco.org. ASCO can provide resources to help you in your advocacy efforts for state legislation.

Update on Federal and State Clinical Trials Legislation


Source:ASCO

Take care

Jimmy B

Call for Patients!!!!!!! NEW CLINICAL TRIAL!!!!!!!!

Jim

We have powerful new immunotherapy treatments for patients with metastatic melanoma using cell transfer techniques (see attached publication).

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

Steven A. Rosenberg M.D., Ph.D.

Chief, Surgery Branch
National Cancer Institute
10 Center Drive MSC 1201
CRC Room 3-3940
Bethesda, MD 20892

301-496-4164

sar@nih.gov

Adoptive Cell Therapy for Patients With Metastatic Melanoma: Evaluation of Intensive Myeloablative Chemoradiation Preparative Regimens


Mark E. Dudley, James C. Yang, Richard Sherry, Marybeth S. Hughes, Richard Royal, Udai Kammula,
Paul F. Robbins, JianPing Huang, Deborah E. Citrin, Susan F. Leitman, John Wunderlich, Nicholas P. Restifo,
Armen Thomasian, Stephanie G. Downey, Franz O. Smith, Jacob Klapper, Kathleen Morton,
Carolyn Laurencot, Donald E. White, and Steven A. Rosenberg


Purpose
The two approved treatments for patients with metastatic melanoma, interleukin (IL)-2 and dacarbazine, mediate objective response rates of 12% to 15%. We previously reported that adoptive cell therapy (ACT) with autologous antitumor lymphocytes in lymphodepleted hosts mediated objective responses in 51% of 35 patients. Here, we update that study and evaluate the safety and efficacy of two increased-intensity myeloablative lymphodepleting regimens.

Patients and Method

We performed two additional sequential trials of ACT with autologous tumor-infiltrating lymphocytes (TIL) in patients with metastatic melanoma. Increasing intensity of host preparative lymphodepletion consisting of cyclophosphamide and fludarabine with either 2 (25 patients) or 12 Gy (25 patients) of total-body irradiation (TBI) was administered before cell transfer. Objective
response rates by Response Evaluation Criteria in Solid Tumors (RECIST) and survival were evaluated. Immunologic correlates of effective treatment were studied.

Results

Although nonmyeloablative chemotherapy alone showed an objective response rate of 49%,
when 2 or 12 Gy of TBI was added, the response rates were 52% and 72% respectively.
Responses were seen in all visceral sites including brain. There was one treatment-related death in the 93 patients. Host lymphodepletion was associated with increased serum levels of the lymphocyte homeostatic cytokines IL-7 and IL-15. Objective responses were correlated with the telomere length of the transferred cells.


Conclusion

Host lymphodepletion followed by autologous TIL transfer and IL-2 results in objective responserates of 50% to 70% in patients with metastatic melanoma refractory to standard therapies.

J Clin Oncol 26:5233-5239. Published by the American Society of Clinical Oncology

The paper is upload in my shared files : (see Shared Files)

Dudley JCO '08 Adoptive Cell Therapy for Patients With Metastatic

Most Cancer Clinical Trials Go Unpublished

Findings from fewer than one in five registered cancer clinical trials are published in peer-reviewed journals, according to a study that appeared September 15 in The Oncologist. This finding, the authors state, raises the concern of publication bias in cancer clinical trials.

Drs. Scott Ramsey and John Scoggins of the Fred Hutchinson Cancer Research Center and the University of Washington found that between 1999 and 2007, only 17.6 percent of cancer-related trials registered with ClinicalTrials.gov (the federal registry for clinical trials of interventions for serious or life-threatening conditions) went on to be published in widely accessible journals listed in the PubMed.gov online database.

The researchers also found evidence of a selection bias on the part of investigators, who are less likely to publish results of a trial that did not meet its endpoints. Though more than 94 percent of the registered, industry-sponsored trials were never published, three-fourths of those in PubMed.gov reported positive results. By comparison, 59 percent of NCI-supported trials were published, half of which reported negative results.

In a related commentary, Dr. James H. Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis, wrote that "the apparent lack of access to the final efficacy and toxicity data…poses multiple scientific and ethical questions." He described an NCI clinical trials database project expected to launch in 2009 that will address this problem by requiring administrative and outcome data for all intervention studies that receive NCI support.

The Oncologist is also considering creating a peer-reviewed, searchable venue for "well-executed trials that fail to meet positive endpoints," wrote Editor-in-Chief Dr. Bruce A. Chabner and Senior Editor Dr. Gregory A. Curt, for trials that are "'negative' in a sense, but valuable nonetheless."

National Cancer Institute Bulletin
September 23, 2008 • Volume 5 / Number 19

LET THE PATIENT BEWARE!!!!!!!!

Jimmy B