rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: LifeCell; Pharmacia
• Treatments: Carboplatin

Criteria

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.