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

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 3

Conditions

Sarcoma

Treatments

Drug: rhTPO

Study type

Interventional

Funder types

Other

Identifiers

NCT00283582

DM00-435

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

13+ years old

Volunteers

Accepts 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