rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
Completed · Not applicable
Conditions studied: Neoplasms, Gynecologic
In brief
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
Key facts
- Study ID
- NCT00038012
- Run by
- M.D. Anderson Cancer Center
- People needed
- 33
- Starts
- 1999-07-23
- Expected to finish
- 2004-06-01
- Last updated by the study team
- 2018-11-01
Who can join
Age: 15 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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