Soft Tissue Sarcoma Clinical Trial
Official title:
High-Dose Chemotherapy With Tandem Peripheral Blood Stem Cell (PBSC) Rescue for the Treatment of High-Risk Pediatric Solid Tumors.
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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