Actively Recruiting
Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors
Led by Peter Zage · Updated on 2025-08-28
18
Participants Needed
2
Research Sites
465 weeks
Total Duration
On this page
Sponsors
P
Peter Zage
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologic confirmation of a solid tumor, including CNS tumors, at initial diagnosis or relapse with progressive, recurrent, or refractory disease
- Measurable or evaluable disease documented within 4 weeks before starting study therapy
- Lansky play or Karnofsky performance score of 40 or higher
- Fully recovered from acute side effects of prior chemotherapy, immunotherapy, or radiotherapy except blood counts meeting eligibility
- Steroid use allowed only if stable or decreasing dose for at least 1 week before starting therapy; no increasing steroids for CNS disease
- Female patients of childbearing potential must agree to use effective contraception during the study; male patients must also agree to use contraception
You will not qualify if you...
- Severe or uncontrolled systemic disease
- Presence of cardiac disease
- Blood pressure above the 95th percentile for age or above 140/90 for adults uncontrolled by oral medication at study start
- Women who are pregnant or breastfeeding
- Prior treatment with cabozantinib
- Major surgery within 8 weeks before starting study therapy
- Previous allogeneic stem cell transplant or total body irradiation
- Therapeutic anticoagulation in patients with intracranial tumors/metastases
- Therapeutic anticoagulation with oral anticoagulants or platelet inhibitors in patients without CNS tumors
- Clinically significant gastrointestinal bleeding in the past 6 months or signs of pulmonary hemorrhage in the past 3 months
- Radiographic evidence of cavitating pulmonary lesions or tumor invading major blood vessels
- Evidence of tumor invading gastrointestinal tract or airway tumors within 28 days before first cabozantinib dose
- Thromboembolic event requiring anticoagulation within 6 months before study start
- Gastrointestinal disorders with high risk of perforation or fistula
- Inability to swallow intact tablets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
P
Peter Zage, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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