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OpenTrials
Completed

NCT Number: NCT00038012

rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

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

Completed

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrombopoietin

Drug

Platelet-pheresis

Procedure

carboplatin

Drug

Other names: Paraplatin

Primary outcomes

  1. Response Rate

    Time frame: Continuous

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • LifeCell
  • Pharmacia

Registry information

Official study title

A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
May 27, 2002
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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