Cabozantinib and Isotretinoin in Treating Children with Relapsed or Refractory Solid Tumors

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Solid Tumor Unknown Primary	NCT ID:	NCT03611595
Trial Phases:	Phase I	Protocol IDs:	171971 (primary) NCI-2018-02497
Eligibility:	2 - 26 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	UC San Diego Medical Center - Hillcrest
NCI Full Details:	http://clinicaltrials.gov/show/NCT03611595

Summary

This phase I trial studies the best dose and side effects of cabozantinib when given in combination with isotretinoin in treating children with solid tumors that have come back (relapsed) or do not respond to treatment (refractory). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin is a drug closely related to vitamin A and it may to help stop the growth and spread of tumor cells. Giving cabozantinib and isotretinoin may work better at treating solid tumors.

Objectives

PRIMARY OBJECTIVES:
I. To determine the safety, dose-limiting toxicities, and maximum tolerated dose of cabozantinib s-malate (cabozantinib) in combination with isotretinoin (13-cis-retinoic acid) in patients with relapsed or refractory solid tumors including tumors of the central nervous system (CNS).

SECONDARY OBJECTIVES:
I. To assess progression-free survival (PFS) and objective tumor response rates in children with relapsed and refractory solid tumors treated with cabozantinib plus 13-cis-retinoic acid in the context of a phase I trial.
II. To evaluate the pharmacodynamics of the combination of cabozantinib and 13-cis-retinoic acid by measuring inhibition of RET phosphorylation via plasma inhibitory activity (PIA) assays.

EXPLORATORY OBJECTIVES:
I. To measure and compare the levels of angiogenic markers in the plasma of patients at the time of diagnosis and after treatment with cabozantinib.
II. To determine biomarkers of response to cabozantinib therapy through reverse phase protein microarray (RPPA).

OUTLINE: This is a dose-escalation study of cabozantinib s-malate.

Patients receive cabozantinib s-malate orally (PO) on days 1-28, and isotretinoin PO twice daily (BID) for 14 consecutive days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.