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Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283582
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : October 30, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: rhTPO Phase 3

Detailed Description:
To evaluate the effectiveness of intravenous rhTPO vs. placebo as primary prophylaxis in reducing the cumulative proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia (platelet count <15,000) during the first four study cycles. To evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis, the impact of rhTPO prophylaxis on health economics/cost effectiveness, and patient quality of life. To assess the safety of multiple IV doses of rhTPO.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
Study Start Date : June 2001
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. CBC with diff. at least three times a week and daily if platelet less than 50,000. Chemistry, coagulation, urinalysis performed at baseline and at end of cycle if necessary.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Confirmed new diagnosis of moderate or high-grade sarcoma (except leiomyosarcoma of gastrointestinal origin)
  • Must have high risk disease by American Joint Committee on Cancer (AJCC) Staging System Stage IIC, III, or IV
  • Must have recovered from surgery for a minimum of 2 weeks
  • Must be scheduled for a minimum of 4 cycles of AI therapy
  • Must be 13 years or older
  • Must have ECOG performance status of 0, 1, or 2.
  • Must have life expectancy of at least 12 weeks.
  • Left ventricular ejection fraction must be more than 50%.
  • Laboratory data within normal limits.

Exclusion Criteria:

  • Prior front-line standard or experimental therapy for sarcoma
  • History of bone marrow and or peripheral blood progenitor cell transplantation
  • Prior pelvic radiation or radiation therapy to more than 25% of bone marrow reserves
  • Prior treatment with megakaryocyte growth and differentiation factor
  • Prior treatment with rhTPO
  • History of platelet disorder
  • History of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis within the past 12 months
  • Pregnant or lactating women
  • Use of anticoagulants such as coumadin, heparin, etc.
  • Known HIV or hepatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283582

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Saroj Vadhan-Raj, M.D. UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00283582    
Other Study ID Numbers: DM00-435
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type