Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Sol… (NCT03611595) | Clinical Trial Compass
RecruitingPhase 1
Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors
United States18 participantsStarted 2018-08-28
Plain-language 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)
Who can participate
Age range2 Years – 26 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patients must have documentation of either measurable or evaluable disease within 4 weeks of onset of study therapy
✓. Performance Status - Lansky play or Karnofsky score of ≥40
✓. 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
Exclusion criteria
✕. Evidence of severe or uncontrolled systemic disease
✕. Cardiac Disease
✕. Blood pressure \>95th percentile for age (either systolic or diastolic) or \>140/90 for patients \>18 years of age and uncontrolled by oral medication at onset of study therapy
✕. Women who are currently pregnant or breastfeeding.
✕. Prior therapy with cabozantinib at any time.
✕. Major surgery within 8 weeks before starting study therapy.
✕. Prior treatment with allogeneic stem cell transplantation or total body irradiation (TBI)
What they're measuring
1
maximum tolerated dose of cabozantinib plus 13-cis-retinoic acid