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rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin | Clinical Trials | Clareo Health

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rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

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

NCT00038012•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

15 - No limit years

Sex

FEMALE

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.
+3 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

July 23, 1999

Primary Completion Date

June 1, 2004

Completion Date

June 1, 2004

Last Updated

November 1, 2018

Enrollment

ACTUAL participants

Conditions

Neoplasms, Gynecologic

Interventions

Thrombopoietin

DRUG

Platelet-pheresis

PROCEDURE

Carboplatin

DRUG