NCT00006386

Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

Official Title:

A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study
* Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter
* No well-differentiated or anaplastic astrocytomas or multifocal glioma
* No tumors originating in the brainstem
* No residual tumor within 10 mm of optic chiasm
* No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin greater than 9 g/dL
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL
* Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal

Renal:

* Creatinine less than 1.8 mg/dL
* Blood urea nitrogen (BUN) less than 30 mg/dL

Pulmonary:

* Chest x-ray normal OR
* Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neurologic functional status 0-3
* No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* Concurrent anticonvulsants allowed

Disease(s) and\or Condition(s)

Brain and Central Nervous System Tumors

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: carmustine
    • Description:
    • Arm Group Labels: External beam radiotherapy with stereotactic boost
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels: External beam radiotherapy with stereotactic boost
    • Type: RADIATION
    • Name: stereotactic radiosurgery
    • Description:
    • Arm Group Labels: External beam radiotherapy with stereotactic boost
Sponsor
  • Radiation Therapy Oncology Group