Treatment

test

Abuse in the FDA Accelerated Drug Program

Washington, DC: Representative Edward J. Markey (D-MA), today released a staff report: Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process. The report reveals that the majority of pharmaceutical companies benefiting from the Food and Drug Administration (FDA)’s “accelerated approval” process, a mechanism designed to expedite drugs for patients with life-threatening illnesses, have not conducted the post-marketing studies that are required by law on a timely basis.

New Procedure Could Help Preserve Women's Eggs

A new procedure could help women have children after cancer treatments that might leave them infertile. A study in mice found a new method for freezing eggs -- called vitrification -- kept 90 percent of the female's eggs alive after they were thawed. The one catch with this method: Women have to undergo hormone therapy before the eggs are removed.

That might not be possible for women who need to start chemotherapy or radiation immediately. Researchers stress more studies are needed. So far only one woman has had the process done.

Trial: Preventing Graft-versus-Host Disease

Name of the Trial

Randomized Pilot Study of Donor Th2 Cells Generated In Vitro by Sirolimus Treatment with or without Oral Sirolimus versus Oral Sirolimus Alone for Prevention of Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Hematologic Malignancies (NCI-04-C-0055). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0055.

Principal Investigator

Rituxan plus Temodar Effective for Primary Central Nervous System Lymphoma

Researchers from Italy have reported that the combination of Rituxan (rituximab) and Temodar (temozolomide) is an effective treatment regimen for patients with primary central nervous system (CNS) non-Hodgkin’s lymphoma (NHL). This phase II study was presented at the 2005 meeting of the American Society of Clinical Oncology in Orlando, Florida, May 13-17 2005.

New drug in phase II trial for peripheral T-cell lymphoma

Gloucester Pharmaceuticals reported on data from a clinical trial in patients with cutaneous T-cell lymphoma of its lead product candidate, FK228 (depsipeptide), presented at the ASCO Meeting held recently in Orlando, Florida. The studies were sponsored by the US NCI and conducted under a Cooperative Research and Development Agreement (CRADA) between Gloucester Pharmaceuticals and the NCI.

Rituxan for First-Line Treatment of Follicular Lymphoma

The monoclonal antibody rituximab (Rituxan®), when added to standard chemotherapy as a first-line treatment for follicular lymphoma, significantly delayed the progression of the disease and produced higher response rates, according to findings reported at the American Society of Clinical Oncology (ASCO) annual meeting last week by Dr. Kevin Imrie of the Toronto-Sunnybrook Regional Cancer Center in Canada.

Clinical Trial: Ginger Treatment For Cancer-Related Nausea and Vomiting

Phase II Randomized Study of Ginger in Patients with Cancer and Chemotherapy-Induced Nausea and Vomiting (CCUM-0201). See the protocol summary at http://cancer.gov/clinicaltrials/CCUM-0201. Principal Investigator: Dr. Suzanna Zick, University of Michigan Integrative Medicine.

Why Is This Trial Important?

Hodgkin's Patient and Medarex Reach Agreement

I wrote 2 blogs ago about Amanda, who has late stage Hodgkin's which has been resistant to conventional treatment. I received an e-mail today:

The past few days and weeks have been very difficult and challenging for the Twellman and Dieppa families and for Medarex. Mr. Drakeman, the President and CEO of Medarex, and the family worked closely together on some very complex and emotional issues. We are pleased to announce that a resolution has been reached, which meets the needs of the family and the goals of Medarex.

Hodgkins Patient Needs Experimental Drug

Amanda Twellman-Dieppa is a 22 year old with NS Hodgkin's Lymphoma, stage 4b. She was diagnosed at 16, went through chemo and radiation and was in remission until she relapsed at 19 years old. She went through a grueling stem cell transplant and received a lifetime amount of radiation and once again went into remission until February 25, 2005. Her website is http://saveamanda.com/

After a Spenectomy: Follow-on Care

Prompted by a blog below, Mary writes: "I had Hodgkins Stage 2A and was given 6 cycles of ABVD finishing last October. I only have the odd occasion of numbness in one finger tip. Unfortunately my sister who had stage 4B and a splenectomy as a 17 year old died when aged 34. She was not given any medication and got a pneumococcal infection which gave her septicaemia after being bitten by a pet rabbit. She had been so well for so many years and had three children. We thought she had flu.