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Summary

for people ages 3–20 (full criteria)
at Oakland, California and other locations
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 Glioma Nervous System Neoplasms Central Nervous System Neoplasms

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/mm3

  • Platelet count ≥ 100,000/mm3 (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 and Research Center Oakland
    Oakland, California, 94609, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • 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
January 5, 2017