Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

NCT ID: NCT00003464

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-09-30
• Study Completion Date: 2003-08-31

Brief Summary

RATIONALE: 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 temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

Detailed Description

OBJECTIVES:

• Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
• Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
• Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: This study will accrue 50 patients.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

temozolomide

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy
• At least 1 bidimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Greater than 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT less than 2.5 times ULN
• Alkaline phosphatase less than 2 times ULN

Renal:

• BUN less than 1.5 times ULN
• Creatinine less than 1.5 times ULN

Other:

• Must be neurologically stable
• No systemic disease
• No acute infection requiring intravenous antibiotics
• No frequent vomiting
• No other medical condition that would interfere with oral medication intake such as partial bowel obstruction
• No prior or concurrent malignancies except:

• Surgically cured carcinoma in situ of the cervix
• Basal or squamous cell carcinoma of the skin
• HIV negative
• No AIDS-related illness
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy
• No concurrent biologic therapy (growth factors or erythropoietin)

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

• No prior radiation therapy
• No prior interstitial brachytherapy
• No prior radiosurgery to the brain
• Not requiring immediate radiation therapy
• No concurrent radiotherapy

Surgery:

• Recovered from any effects of prior surgery
• At least 2 weeks since prior surgical resection

Other:

• No other concurrent investigational drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Duke UMC

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke University

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-1171-01-6R4

Identifier Type: -

Identifier Source: secondary_id

DUMC-1016-97-7

Identifier Type: -

Identifier Source: secondary_id

DUMC-1056-98-7R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-1058-98-7R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-1171-00-6R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-1231-99-7R2

Identifier Type: -

Identifier Source: secondary_id

DUMC-97081

Identifier Type: -

Identifier Source: secondary_id

NCI-G98-1465

Identifier Type: -

Identifier Source: secondary_id

CDR0000066498

Identifier Type: OTHER

Identifier Source: secondary_id

1171

Identifier Type: -

Identifier Source: org_study_id