rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Pharmacia
LifeCell
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038012
First received: May 24, 2002
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin
| Condition | Intervention |
|---|---|
|
Neoplasms, Gynecologic |
Drug: Thrombopoietin Procedure: Platelet-pheresis Drug: Carboplatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Response Rate [ Time Frame: Continuous ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | September 1999 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: rhTPO-Derived Autologous Platelets Transfusion |
Drug: Thrombopoietin
Procedure: Platelet-pheresis
Drug: Carboplatin
Other Name: Paraplatin
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038012
Locations
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pharmacia
LifeCell
Investigators
| Study Chair: | Saroj Vadhan-Raj, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038012 History of Changes |
| Other Study ID Numbers: | GYN97-310 |
| Study First Received: | May 24, 2002 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Dose-intensified carboplatin autologous cryopreserved platelets thrombopoietin Gynecologic malignancy |
Additional relevant MeSH terms:
|
Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013