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rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

Primary Purpose

Neoplasms, Gynecologic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrombopoietin
Platelet-pheresis
Carboplatin
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Gynecologic focused on measuring Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rhTPO-Derived Autologous Platelets Transfusion

Arm Description

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Pharmacia, LifeCell
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1. Study Identification

Unique Protocol Identification Number
NCT00038012
Brief Title
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 23, 1999 (Actual)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Pharmacia, LifeCell

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Gynecologic
Keywords
Dose-intensified carboplatin, autologous cryopreserved platelets, thrombopoietin, Gynecologic malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhTPO-Derived Autologous Platelets Transfusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Thrombopoietin
Intervention Type
Procedure
Intervention Name(s)
Platelet-pheresis
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
Continuous

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saroj Vadhan-Raj, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin

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