RECRUITING

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

Conditions

Solid Tumor 13-cis-Retinoic Acid Children Relapsed Solid Tumors Refractory Solid Tumors Solid Tumors cancer cabozantinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A National Phase I Study of Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors

Quick Facts

Study Start:2018-08-28

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03611595

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 26 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 6. Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study. Male subjects must agree to use an adequate method of contraception for the course of the study	1. Evidence of severe or uncontrolled systemic disease 2. Cardiac Disease 3. 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 4. Women who are currently pregnant or breastfeeding. 5. Prior therapy with cabozantinib at any time. 6. Major surgery within 8 weeks before starting study therapy. 7. Prior treatment with allogeneic stem cell transplantation or total body irradiation (TBI) 8. Therapeutic anticoagulation with heparin, LMWH , or any other agents are not allowed in subjects with intracranial tumors/metastatses. 9. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel) in patients without primary or metastatic CNS tumors 10. The subject has experienced any of the following: 1. clinically-significant GI bleeding within 6 months before the first dose of study treatment; 2. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment. 11. The subject has radiographic evidence of cavitating pulmonary lesion(s) and/or the subject has tumor invading any major blood vessels; 12. The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib 13. thromboembolic event requiring therapeutic anticoagulation within 6 months of onset of study treatment 14. GI disorders particularly those associated with a high risk of perforation or fistula formation 15. Inability to swallow intact tablets

Inclusion Criteria

Exclusion 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
6. Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study. Male subjects must agree to use an adequate method of contraception for the course of the study

1. Evidence of severe or uncontrolled systemic disease
2. Cardiac Disease
3. 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
4. Women who are currently pregnant or breastfeeding.
5. Prior therapy with cabozantinib at any time.
6. Major surgery within 8 weeks before starting study therapy.
7. Prior treatment with allogeneic stem cell transplantation or total body irradiation (TBI)
8. Therapeutic anticoagulation with heparin, LMWH , or any other agents are not allowed in subjects with intracranial tumors/metastatses.
9. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel) in patients without primary or metastatic CNS tumors
10. The subject has experienced any of the following:
1. clinically-significant GI bleeding within 6 months before the first dose of study treatment;
2. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.
11. The subject has radiographic evidence of cavitating pulmonary lesion(s) and/or the subject has tumor invading any major blood vessels;
12. The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
13. thromboembolic event requiring therapeutic anticoagulation within 6 months of onset of study treatment
14. GI disorders particularly those associated with a high risk of perforation or fistula formation
15. Inability to swallow intact tablets

Contacts and Locations

Study Contact

Peter Zage, MD

CONTACT

858-534-6494

pzage@ucsd.edu

Principal Investigator

Peter Zage

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Peter Zage

Peter Zage, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-28

Study Completion Date2026-08

Study Record Updates

Study Start Date2018-08-28

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

13-cis-Retinoic Acid
Children
Relapsed Solid Tumors
Refractory Solid Tumors
Solid Tumors
cancer
cabozantinib

Additional Relevant MeSH Terms

Solid Tumor