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Recruiting Phase 1 NCT03611595

Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors

Trial Parameters

Condition Solid Tumor
Sponsor Peter Zage
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 18
Sex ALL
Min Age 2 Years
Max Age 26 Years
Start Date 2018-08-28
Completion 2026-08
Interventions
Cabozantinib13-cis-retinoic acid

Brief Summary

This study is being conducted in order to determine the safety, dose-limiting toxicities, and maximum tolerated dose of cabozantinib in combination with 13-cis-retinoic acid in patients with relapsed or refractory solid tumors including tumors of the central nervous system (CNS)

Eligibility Criteria

Inclusion Criteria: 1. Patients must have had histologic verification of a solid tumor, including tumors of the CNS, at the time of initial diagnosis or relapse, with disease that has progressed on standard therapy, relapsed after standard therapy, or for which no standard curative therapy is known 2. Patients must have documentation of either measurable or evaluable disease within 4 weeks of onset of study therapy 3. Performance Status - Lansky play or Karnofsky score of ≥40 4. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrolment with the exception of hematologic parameters (absolute neutrophil count, hemoglobin, platelet count), which need to have recovered to meet eligibility criteria 5 Steroids are permitted for control of emesis and for symptom management in patients with intracranial metastases. However, patients with known CNS disease or CNS metastases who require increas

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