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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rhTPO
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcoma

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UT MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2006
Last Updated
October 29, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00283582
Brief Title
Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rhTPO
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saroj Vadhan-Raj, M.D.
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT 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

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

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