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Summary

Eligibility
for people ages 3–20
Location
at Oakland, California and other locations
Dates
study started

Description

Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.

Official Title

A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

Details

OBJECTIVES:

Primary

  • Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.

Secondary

  • Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.
  • Determine quality of life of patients treated with this regimen.
  • Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Keywords

Brain Tumor Central Nervous System Tumor childhood oligodendroglioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood visual pathway and hypothalamic glioma untreated childhood cerebellar astrocytoma untreated childhood visual pathway and hypothalamic glioma

Eligibility

For people ages 3–20

DISEASE CHARACTERISTICS:

  • Histologically confirmed* low-grade glioma, including any of the following:
  • Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
  • Diffuse astrocytoma, including any of the following subtypes:
  • Fibrillary astrocytoma
  • Gemistocytic astrocytoma
  • Subependymal giant cell astrocytoma
  • Pleomorphic xanthoastrocytoma
  • Low-grade oligoastrocytoma
  • Low-grade oligodendroglioma
  • Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
  • Measurable disease by radiography
  • Meets any of the following criteria:
  • Progressive nonresectable disease
  • Any location in the brain
  • Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
  • Has undergone biopsy only
  • Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
  • Prior chemotherapy optional (for patients ≥ 10 years of age)
  • No type-1 neurofibromatosis
  • No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

  • 3 to 20

    Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100% (for patients> 16 years of age) OR
  • Lansky 50-100% (for patients ≤ 16 years of age)

    Life expectancy

  • At least 1 year

    Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 10.0 g/dL (transfusions allowed)

    Hepatic

  • Not specified

    Renal

  • Not specified

    Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry
  • Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

    Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

    Endocrine therapy

  • Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry
  • Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

    Radiotherapy

  • No prior radiotherapy

    Surgery

  • See Disease Characteristics

    Other

  • No other concurrent anticancer therapy

Locations

  • Children's Hospital Central California
    Madera, California, 93638-8762, United States
  • University of California Davis Cancer Center
    Sacramento, California, 95817, United States
  • Kaiser Permanente Medical Center - Oakland
    Sacramento, California, 95825, United States
  • Southern California Permanente Medical Group
    Downey, California, 90027, United States
  • Childrens Hospital Los Angeles
    Los Angeles, California, 90027, United States
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
    Los Angeles, California, 90048-1865, United States
  • Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California, 90095-1781, United States
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
    Long Beach, California, 90801, United States
  • Children's Hospital of Orange County
    Orange, California, 92868, United States
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    Loma Linda, California, 92354, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89109-2306, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00238264
Phase
Phase 2
Study Type
Interventional
Last Updated
November 1, 2016