Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors
Recruitment status was: Recruiting
|Ewing's Sarcoma Soft Tissue Sarcoma Hepatoblastoma Hodgkin's Disease Germ Cell Tumor||Drug: High-Dose Chemotherapy with Tandem PBSC Rescue.||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors.|
- Determine the feasibility and toxicity of tandem PBSC rescue following high dose chemotherapy as consolidation in pediatric patients with high risk solid tumors. [ Time Frame: annually ]
- Evaluate length of remission and long term disease free survival in chemotherapy responsive high-risk pediatric solid tumor patients treated using this approach. [ Time Frame: Annually ]
- Evaluate correlation between cell dose and time to engraftment in high-risk pediatric solid tumor patients treated using this approach. [ Time Frame: Time to engraftment ]
|Study Start Date:||April 1999|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Drug: High-Dose Chemotherapy with Tandem PBSC Rescue.
Significant advances have been made in recent years in the treatment of solid tumors of childhood. However, much of the improvement in survival has been made in low stage and localized disease. Of significance is the fact that the improvements have come in up-front remission rates without translation into significantly high event-free survival(EFS) or overall survival (OS). This is despite the fact that these tumors as a whole are largely chemotherapy responsive.
Recent advances in the understanding of the biology of hematopoeitic stem cells have driven the design of treatment regimens that allow for dose intensification without unacceptable hematologic toxicity. Protocol development has focused on active agents that have a broad range between hematologic and non-hematologic toxicities. This study uses a double autologous peripheral blood stem cell rescue (PBSC) following dose-intensive chemotherapy for the treatment of high-risk pediatric solid tumors. This study utilizes PBSC to limit the risk of tumor cell contamination while retaining prompt hematologic recovery from these highly intensified treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179816
|Contact: Morris Kletzel, M.D.||773.880.4000 ext firstname.lastname@example.org|
|Contact: Meredith Marshall||773-880-3459||MeMarshall@childrensmemorial.org|
|United States, Illinois|
|Children's Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Morris Kletzel, M.D.||Ann & Robert H Lurie Children's Hospital of Chicago|