rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

M.D. Anderson Cancer Center

Status

Completed

Conditions

Neoplasms, Gynecologic

Treatments

Drug: Thrombopoietin

Drug: Carboplatin

Procedure: Platelet-pheresis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00038012

GYN97-310

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

Female

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.