AS-101 (Ossirene) induces the production of several hematopoietic growth factors in vitro, and protects mice from hematologic toxicity of external beam radiation or chemotherapy in vivo. The BRMP previously demonstrated similar effects of IL-1 before chemo/radiotherapy in animals, while a BRMP clinical trial demonstrated acceleration of platelet recovery from high-dose carboplatin when IL-1 followed chemotherapy. This protocol tests the ability of AS-101, by two doses and several schedules, to produce similar effects with high-dose carboplatin in pts. The objectives of this study are: 1) determine the toxicity of Ossirene and high dose carboplatin, 2) determine whether the sequence and/or schedule of drug is important, 3) determine which dose of Ossirene is superior in limiting bone marrow suppression from carboplatin. Pts. received carboplatin 800 mg/m2 and Ossirene, 3 or 6 mg/m2 pre or post carboplatin. Nine pts. were entered on this study. There were 2 minor responses. Pts. experienced significant hematologic toxicity, however toxicity did not prevent treatment.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Intramural Research (Z01)
Project #
1Z01SC009395-03
Application #
2464537
Study Section
Special Emphasis Panel (LP)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
1996
Total Cost
Indirect Cost
Name
National Cancer Institute Division of Clinical Sciences
Department
Type
DUNS #
City
State
Country
United States
Zip Code