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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014