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PTC299 in Treating Young Patients With Refractory or Recurrent Primary Central Nervous System Tumors

NCT01158300 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-05-04

No results posted yet for this study

Summary

RATIONALE: PTC299 may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and the best dose of PTC299 in treating young patients with recurrent or refractory primary central nervous system tumors.

Conditions

Interventions

DRUG

VEGF inhibitor PTC299

This is a dose escalation study. Study participants will receive .6 or 1.2 mg/kg orally twice daily or 1.2, 1.5, or 2.0 mg/kg orally three times daily for four consecutive weeks (a course). In the absence of unacceptable toxicity or disease progression, treatment may continue for up to 12 courses (approximately one year)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • PTC Therapeutics

    collaborator INDUSTRY

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Roger J. Packer, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT01158300 on ClinicalTrials.gov