NCT02446431 Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence

Trial Parameters

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Brief Summary

Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug exposure, has been successfully tested in pediatric leukemias with excellent results in terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with little success, but has been implemented usually in the relapsed setting at a time of high tumor burden and disease resistance.

Eligibility Criteria

Inclusion Criteria: 1. The following solid tumors will be studied: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other soft tissue sarcomas 2. Other solid tumors fulfilling the remainder of eligibility criteria and available historical data to determine time to tumor progression 3. Expected time to progression of \< 2 years, based on historical data 4. All patients will have completed front-line therapy 5. All patients will be in remission from their primary diagnosis 6. All patients will start metronomic therapy within 6 weeks of completion of front-line treatment 7. All patient will have recovered from previous toxicities 8. All patients or their parents/legal guardian will have signed an informed consent document 9. All institutional eligibility criteria will be meet 10. Age: Patients must be ≥ 12 months and \<31 years of age at the time of study entry 11. Patients must have had histologic verification of malignancy at original diagnosis 12. Patients must have a Lansky or Karnofsky

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