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Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

NCT00100802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2023-02-15

Study results available
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Summary

This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

Conditions

  • Anaplastic Astrocytoma
  • Central Nervous System Neoplasm
  • Glioblastoma
  • Gliosarcoma
  • Spinal Cord Neoplasm

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lomustine

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Regina I Jakacki · Children's Oncology Group

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
2005-03-21
Primary Completion
2012-09-01
Completion
2017-06-30

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 NCT00100802 on ClinicalTrials.gov