Cancer Trials: 60% to 70% of subjects are children – WSJ

July 26, 2002

Cancer Trials: 60% to 70% of subjects are children – Wall Street Journal

The Wall Street Journal reports that there is a shortage of people volunteering to test experimental cancer drugs.

“Overall, only 3% to 4% of cancer patients participate in trials. Most of those participants

are children; about 60% to 70% of children with cancer participate in trials.”

Is anyone keeping track–How many children who participated in medical research have benefited, how many have been harmed?

Daniella Rogers was just 16 months old when she diagnosed with rhabdomyosarcoma in February 2002. She entered a clinical trial at Washington University, St. Louis, comparing the efficacy of 3 chemotherapy medications with the efficacy of a regimen alternating the same 3 drugs with 1 additional chemotherapy medication.

Daniella died of veno-occlusive disease (VOD), a liver abnormality known to be caused by chemotherapy medications. She developed liver failure, then renal failure, heart failure and cerebral edema. Daniella did not die from her cancer; rather she died from complications of the treatment that was supposed to save her life. Her parents, John and Osaka Rogers are seeking answers to some troubling questions. They should have been told the answer to some of those questions before they signed consent for Daniella:

“Why didn’t we know this could happen? VOD wasn’t mentioned in the informed consent we signed. If we had been informed, we might have been able to obtain the right care for our beautiful daughter in time to save her life.” They say Daniella did not have “a simple, common lab test [that] might have allowed the condition to be diagnosed earlier, quite possibly preventing Daniella’s death.” They found two other families whose children developed VOD–one died, the other was saved.

One hundred children in the US are said to be enrolled in the same study: titled POG D9803: A Randomized Study of Vincristine, Actinomycin D, and Cyclophosphamide (VAC) versus VAC alternating with Vincristine, Topotecan and Cyclophosphamide for Patients with Intermediate Risk Rhabdomyosarcoma. A website in Danniella’s memory is at: http://www.daniellarogers.org/default.htm

~~~~~~~~~~~~~~~~~~~~~~ Wall Street Journal

Health & Technology: Clinical Trials of Cancer Drugs Will Get Funding of $6 Million By Jill Carroll; Jul 22, 2002; B 5

Abstract: Harmon Eyre, chief medical officer of the American Cancer Society, said about 400 new cancer medicines or treatments are ready for clinical trials each year, but only about 100 can be tested at a time. Mr. Eyre said one of the many factors that contributes to patients not knowing about trials is that drug companies don’t widely publicize their trials for fear of giving away trade secrets. He said companies often use the same research institutions for their trials and don’t seek patients outside those several facilities.

WASHINGTON — To speed cancer drugs to market, the government and five major drug makers are jointly funding grants to improve early c! linical trials, the first step in getting cutting-edge cancer treatments to patients.

The grants, totaling $6 million, will go to National Cancer Institute-funded cancer centers to find better ways to perform the early experimental drug trials.

Andrew von Eschenbach, director of the National Cancer Institute, said “if suddenly tomorrow” there were enough patients and available drugs to test all the new cancer therapies ready for trials “frankly we couldn’t handle it.”

The early clinical trials are the first time a drug is tested in people and mainly help determine if the drug is safe. Institutions will have to compete for the money, which will be given out over two years in allotments of five to eight grants.

“This collaboration on cancer trials will serve as a model to help accelerate the pace of clinical trials research in other diseases,” said National Institutes of Health Director Elias Zerhouni.

Cancer researchers say patients oft! en don’t participate in trials because they don’t know about them or there needs to be improvement in infrastructure to perform the trials that are increasingly complex as treatments become more targeted.

“These all have a big impact on the efficiency of our development,” said Mel Sorenson, head of clinical oncology at GlaxoSmithKline PLC. Aventis SA, Bristol-Myers Squibb Co., Eli Lilly & Co. and Novartis AG are also participating in the initiative.

Overall, only 3% to 4% of cancer patients participate in trials. Most of those participants are children; about 60% to 70% of children with cancer participate in trials.

Harmon Eyre, chief medical officer of the American Cancer Society, said about 400 new cancer medicines or treatments are ready for clinical trials each year, but only about 100 can be tested at a time. Mr. Eyre said one of the many factors that contributes to patients not knowing about trials is that drug companies don’t widely publici! ze their trials for fear of giving away trade secrets. He said companies often use the same research institutions for their trials and don’t seek patients outside those several facilities.

An NCI letter to cancer-center directors outlining the grant program says special attention will be given to proposals that would increase the access of minorities and the elderly in the trials, groups that have been underrepresented in the past. Centers will have to submit proposals for addressing any number of “barriers” that make it harder for the trials to run and, if successful, their plan will be sent to other centers facing similar problems.

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