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Therapeutic Areas: Oncology
Disease Category: Solid Tumors

Trial Information

Dasatinib with Ifosfamide, Carboplatin, Etoposide: A Pediatric Phase I/II Trial

You have/your child has been asked to participate in this research study because you/your child have a recurrent cancer (cancer that has returned). 

If you/your child enter Phase I of this study, the purpose is to combine Dasatinib (SPRYCEL®) with cytotoxic chemotherapy, Ifosfamide, Carboplatin, and Etoposide (ICE). We want to find the highest safe dose (maximally tolerated dose [MTD]) of Dasatinib (SPRYCEL®) that can be given immediately following ifosfamide, carboplatin and etoposide (D-ICE) without causing severe side effects as a re-induction regimen (different treatment introduced when remission is not achieved). Lastly, we hope to learn more about the biology of Dasatinib (SPRYCEL®) in treating cancer. Your/your child's participation in this study is expected to last up to about 6 months (6 courses) if your/your child’s tumor is not getting worse and you are/your child is not experiencing unmanageable side effects. You/your child may receive an additional 6 months of Dasatinib (SPRYCEL®) alone if you/your child successfully complete the first 6 months of treatment. After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed for as long as you/your child will allow.

If you/your child enter Phase II of this study, the purpose is to determine the response rate to D-ICE as well as the overall progression free survival in subjects with recurrent sarcoma and other solid tumors. In addition, subjects with high risk, newly diagnosed metastatic solid tumors (e.g., osteosarcoma, Ewings sarcoma, rhabdomyosarcoma), will also be studied to determine response rate and overall progression free survival to D-ICE. Lastly, we hope to learn more about the biology of Dasatinib (SPRYCEL®) in treating cancer. Your/your child's treatment on this study is expected to last up to about 12 months if your/your child’s tumor is not getting worse and you are/your child is not experiencing unmanageable side effects. You/your child may receive an additional 6 months of Dasatinib (SPRYCEL®) alone if you/your child complete/s the first 12 months of study treatment. After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed for as long as you/your child will allow.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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