drugset / Trial / NCT00187109

Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy

NCT00187109

Phase 1/2 Completed 40 enrolled St. Jude Children's Research Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.

Timeline

Start
2000-06
Primary completion
2007-02
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human thrombopoietin Protein / enzyme biologic