Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2002 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on October 3, 2002. Last Updated on December 13, 2011 History of Changes

Sponsor:	Duke Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046878

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. O(6)-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining carmustine with O(6)-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: O6-benzylguanine Drug: carmustine	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: O(6)-Benzylguanine Carmustine

U.S. FDA Resources

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

Detailed Description:

OBJECTIVES:

Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.
Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy.

PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy
Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with a medical contraindication for MRI) with a baseline scan obtained at the corticosteroid dose the patient is receiving on the day of treatment

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin greater than 10 g/dL

Hepatic

Bilirubin normal
SGOT no greater than 2.5 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL
BUN no greater than 25 mg/dL

Pulmonary

DLCO greater than 75% predicted

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics
Concurrent corticosteroids allowed if on stable dose for 3 days before study

Radiotherapy

See Disease Characteristics

Surgery

No more than 28 days since prior surgical resection or biopsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046878

Sponsors and Collaborators

Duke Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Henry S. Friedman, MD

Duke Cancer Institute

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00046878 History of Changes
Other Study ID Numbers:	CDR0000256332, DUMC-3318-01-12, NCI-5632
Study First Received:	October 3, 2002
Last Updated:	December 13, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

Neoplasms by Site
Nervous System Diseases
Carmustine
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012