rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038012
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Neoplasms, Gynecologic Drug: Thrombopoietin Procedure: Platelet-pheresis Drug: Carboplatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 23, 1999
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: rhTPO-Derived Autologous Platelets Transfusion Drug: Thrombopoietin
Procedure: Platelet-pheresis
Drug: Carboplatin
Other Name: Paraplatin

Primary Outcome Measures :
  1. Response Rate [ Time Frame: Continuous ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038012

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Saroj Vadhan-Raj, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038012     History of Changes
Other Study ID Numbers: GYN97-310
First Posted: May 27, 2002    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Keywords provided by M.D. Anderson Cancer Center:
Dose-intensified carboplatin
autologous cryopreserved platelets
Gynecologic malignancy

Additional relevant MeSH terms:
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Antineoplastic Agents