Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy
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.
Germ Cell Tumors
Drug: Recombinant Human Thrombopoietin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide|
- To evaluate the safety of recombinant human thrombopoietin following chemotherapy which includes ifosfamide, carboplatin and etoposide for solid tumors and lymphoma.
- To evaluate whether recombinant human thrombopoietin will reduce the time necessary for platelet counts to recover following chemotherapy.
|Study Start Date:||June 2000|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187109
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Najat C. Daw, M.D.||St. Jude Children's Research Hospital|