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


N/A
15 Years
N/A
Not Enrolling
Female
Neoplasms, Gynecologic

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

Continuous

Safety Issue:

No

Principal Investigator

Saroj Vadhan-Raj, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

GYN97-310

NCT ID:

NCT00038012

Start Date:

September 1999

Completion Date:

June 2004

Related Keywords:

  • Neoplasms, Gynecologic
  • Dose-intensified carboplatin
  • autologous cryopreserved platelets
  • thrombopoietin
  • Gynecologic malignancy
  • Neoplasms
  • Genital Neoplasms, Female

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096