rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

Neoplasms, Gynecologic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038012
• Other study ID #: GYN97-310
• Status: Completed
• Phase: N/A
• Start date: July 23, 1999
• Est. completion date: June 2004

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Neoplasms, Gynecologic

Intervention

Drug:
• Thrombopoietin

Procedure:
• Platelet-pheresis

Drug:
• Carboplatin

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	LifeCell, Pharmacia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		Continuous

External Links

•   UT MD Anderson Cancer Center website