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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Pharmacia LifeCell |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038012 |
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
Condition | Intervention |
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Neoplasms, Gynecologic |
Drug: Thrombopoietin Procedure: Platelet-pheresis Drug: Carboplatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin |
Enrollment: | 31 |
Study Start Date: | September 1999 |
Study Completion Date: | June 2004 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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rhTPO-Derived Autologous Platelets Transfusion: Experimental | Drug: Thrombopoietin Procedure: Platelet-pheresis Drug: Carboplatin |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Saroj Vadhan-Raj, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Saroj Vadhan-Raj, MD / Professor ) |
Study ID Numbers: | GYN97-310 |
Study First Received: | May 24, 2002 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00038012 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dose-intensified carboplatin autologous cryopreserved platelets thrombopoietin Gynecologic malignancy |
Genital Neoplasms, Female Urogenital Neoplasms Carboplatin |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Genital Neoplasms, Female Urogenital Neoplasms Carboplatin Pharmacologic Actions |