- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00038012
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
October 30, 2018 updated by: M.D. Anderson Cancer Center
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: rhTPO-Derived Autologous Platelets Transfusion
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Rate
Time Frame: Continuous
|
Continuous
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 23, 1999
Primary Completion (ACTUAL)
June 1, 2004
Study Completion (ACTUAL)
June 1, 2004
Study Registration Dates
First Submitted
May 24, 2002
First Submitted That Met QC Criteria
May 24, 2002
First Posted (ESTIMATE)
May 27, 2002
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 30, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GYN97-310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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