rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin (NCT00038012) | Clinical Trial Compass
CompletedNot Applicable
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
United States33 participantsStarted 1999-07-23
Plain-language summary
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
Who can participate
Age range15 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.