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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038012

Enrollment

Registered

2002-05-27

Start date

1999-07-23

Completion date

2004-06-30

Last updated

2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Gynecologic

Keywords

Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy

Brief summary

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

Interventions

DRUGThrombopoietin

PROCEDUREPlatelet-pheresis

DRUGCarboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response Rate	Continuous

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026