A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin

INCLUSION CRITERIA:

• Patients with gynecologic malignancy for whom treatment with carboplatin is indicated.
• Age >/= 15 years.
• Adequate hematologic, renal, and hepatic functions.
• Life expectancy >/- 3 months. Karnofsky Performance Status >/= 80.
• Signed informed consent form.

EXCLUSION CRITERIA:

• Patients with rapidly progressive disease.
• Pregnant or lactating women.
• Patients with comorbid condition which renders patients at high risk of treatment complication.
• History of CNS metastasis.
• Patients with significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the 6 months of study entry.
• Prior chemotherapy, immunotherapy, any experimental drug within 4 weeks, use of myeloid (G-CSF or GM-CSF) growth factors within 2 weeks or erythropoietin within 4 weeks.
• Use of any nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks.
• Prior surgery or RT within 2 wks of study entry.
• Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (> 2 weeks).
• History of leukemia.
• History of any platelet disorders including ITP, TTP or bleeding disorders.
• History of > 3 prior chemotherapy regimens (all platinum regimens will be counted as 1 regimen).
• Demonstrated lack of response to platinum-based therapy.