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Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

NCT01644773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-03-22

No results posted yet for this study

Summary

This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of high grade gliomas (HGG). Participants will receive escalating doses until the highest dose is determined. Participants will be enrolled in two strata: stratum A for recurrent/ progressive tumors and stratum B for recently diagnosed patients who have completed standard radiation therapy without progressive disease. Up to 7 dosage levels will be tested. Both drugs are taken orally daily, once per day. Correlative pharmacokinetic and biology studies are planned, as well as advanced methods of magnetic resonance imaging (MRI).

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High-grade Glioma

Interventions

DRUG

Crizotinib

Starting dose level: * Initial Treatment Plan: 130 mg/m\^2 per dose * Modified Treatment Plan per Amendment 1.0: 165 mg/m\^2 per dose The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached. The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors. Cycle 1 (28 days): once a day for 28 days Cycles 2-26 (28 days each): once a day

DRUG

Dasatinib

Starting dose level: 50 mg/m\^2 per dose The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached. The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors. Cycle 1 (28 days): starting on day 3, once a day for 28 days Cycles 2-26 (28 days each): once a day

Sponsors & Collaborators

Principal Investigators

  • Anna Vinitsky, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-27
Primary Completion
2018-03-07
Completion
2018-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644773 on ClinicalTrials.gov