A National Phase I Study of Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors
Peter Zage
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)
Description
Participants will be treated in an open-label, non-randomized phase I trial to determine the safety, dose-limiting toxicities, tolerability, and maximum tolerated dose of cabozantinib combined with 13-cis-retinoic acid in children with relapsed or refractory solid tumors. Eligible Participants must have a histologically confirmed solid tumor at time of initial diagnosis, and have either progressive, recurrent, or refractory disease. Cabozantinib will be given orally once every day with cycles repeated every 4 weeks (28 days, +/- 3 days), with no rest periods between cycles, combined with 13-c…
Eligibility
- Age range
- 2–26 years
- Sex
- All
- Healthy volunteers
- No
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, immunothe…
Interventions
- DrugCabozantinib
Cabozantinib will be given orally once every day with cycles repeated every 4 weeks (28 days, +/- 3 days), with no rest periods between cycles
- Drug13-cis-retinoic acid
13-cis-retinoic acid at 80mg/m2/dose twice daily for two consecutive weeks (14 days) out of every four weeks (28 days, +/- 3 days).
Locations (2)
- Rady Children's Hospital - San DiegoSan Diego, California
- Children's Healthcare of AtlantaAtlanta, Georgia