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Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas

NCT01514201 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-08-13

Study results available
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Summary

This phase I/II trial studies the side effects and the best dose of veliparib when given together with radiation therapy and temozolomide and to see how well they work in treating younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may kill more tumor cells.

Conditions

  • Anaplastic Astrocytoma
  • Brain Stem Glioma
  • Childhood Mixed Glioma
  • Fibrillary Astrocytoma
  • Giant Cell Glioblastoma
  • Glioblastoma
  • Gliosarcoma
  • Untreated Childhood Anaplastic Astrocytoma
  • Untreated Childhood Brain Stem Glioma
  • Untreated Childhood Fibrillary Astrocytoma
  • Untreated Childhood Giant Cell Glioblastoma
  • Untreated Childhood Glioblastoma
  • Untreated Childhood Gliosarcoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Temozolomide

Given PO

DRUG

Veliparib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Patricia Baxter · Pediatric Brain Tumor Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-01
Primary Completion
2018-03-28
Completion
2018-03-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01514201 on ClinicalTrials.gov