rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

This study has been completed.
Sponsor:
Collaborators:
Pharmacia
LifeCell
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038012
First received: May 24, 2002
Last updated: July 31, 2012
Last verified: July 2012
  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
Procedure: Platelet-pheresis
Drug: Carboplatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response Rate [ Time Frame: Continuous ] [ Designated as safety issue: No ]

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

  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
Investigators
Study Chair: Saroj Vadhan-Raj, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038012     History of Changes
Other Study ID Numbers: GYN97-310
Study First Received: May 24, 2002
Last Updated: July 31, 2012
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

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

ClinicalTrials.gov processed this record on April 16, 2014