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rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
This study has been terminated.
First Received: May 24, 2002   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Pharmacia
LifeCell
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038012
  Purpose

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
Neoplasms, Gynecologic
Drug: Thrombopoietin, Carboplatin
Procedure: Platelet-pheresis

MedlinePlus related topics: Blood Transfusion and Donation Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources
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

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 31
Study Start Date: September 1999
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038012

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pharmacia
LifeCell
  More Information

No publications provided

Study ID Numbers: GYN97-310
Study First Received: May 24, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00038012     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Genital Neoplasms, Female
Urogenital Neoplasms
Carboplatin

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Genital Neoplasms, Female
Urogenital Neoplasms
Carboplatin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009