Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children

Phase 2

Terminated

• Conditions: Glioblastoma Multiforme; Malignant Brain Tumor; High Grade Glioma; Anaplastic Astrocytoma
• Interventions: Drug: Cabozantinib

• Registration Number: NCT02885324
• Lead Sponsor: Indiana University

Brief Summary

This pilot will study the feasibility and exploratory efficacy of using Cabozantinib for recurrent or refractory central nervous system tumors for which there are no curative options. Patients will also be followed for safety, time to progression, event free survival and overall survival

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Study Start: 2017-05-18
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-25
• Results First Submitted: 2022-07-21
• Results First Submitted QC: 2022-07-21
• Results First Posted: 2022-08-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib	Cabozantinib	Cabozantininb will be taken daily at a dose of 40 mg/m2. Drug cycles will last 28 days and be continuous for up to 12 months of therapy on study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease Response	6 months	To assess the number of participants with best response of CR, PR, SD or PD. Response criteria are assessed based on the product of the longest diameter and its longest perpendicular diameter.; Complete response (CR): Disappearance of all target lesions Partial response (PR): ≥50% decrease in the sum of the products of the two perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements Stable disease (SD): Neither sufficient decrease in the sum of the products of the two perpendicular diameters of all target lesions to qualify for PR, nor sufficient increase in a single target lesion to qualify for PD.; Progressive Disease (PD): The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	6 months	To assess the number of participants who survived at 6 months.
Number of Participants With Progression Free Survival	6 months	To assess the number of participants who had progression free survival at 6 months.

Trial Locations

Locations (1)

Riley Hospital for Children at IU Health; 🇺🇸 Indianapolis, Indiana, United States