Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006386

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: carmustine Radiation: radiation therapy Radiation: stereotactic radiosurgery	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Carmustine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2001

Detailed Description:

OBJECTIVES:

Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
Determine the short and long-term toxicity of this regimen in these patients.
Determine the feasibility of this regimen in these patients.

OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
SGPT or SGOT less than 2 times normal

Renal:

Creatinine less than 1.8 mg/dL
BUN less than 30 mg/dL

Pulmonary:

Chest x-ray normal OR
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006386

Show 236 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Rupert Schmidt-Ullrich, MD

Massey Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Cardinale R, Won M, Choucair A, et al.: A phase II trial of accelerated radiotherapy using weekly stereotactic conformal boosts for supratentorial glioblastoma multiforme. RTOG-0023. [Abstract] J Clin Oncol 23 (Suppl 16): A-1511, 116s, 2005.

Study ID Numbers:	CDR0000068264, RTOG-BR-0023, RTOG-DEV-1040
Study First Received:	October 4, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006386 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Carmustine
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Glioblastoma Multiforme
Antineoplastic Agents, Alkylating
Gliosarcoma
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Carmustine
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009