Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004204
• Other study ID #: CDR0000067449
• Secondary ID: CPMC-IRB-8622SPR
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: January 3, 2014
• Start date: February 2000

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 patients who have recurrent or progressive malignant glioma.

Description:

OBJECTIVES:

• Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.

• Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.

• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven recurrent or progressive malignant glioma of one of the following types:

• Anaplastic oligodendroglioma or oligoastrocytoma

• Anaplastic astrocytoma

• Glioblastoma multiforme (stratum closed to accrual 11/30/01)

• Patients who have failed radiotherapy are eligible

• Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 10 g/dL

Hepatic:

• SGOT or SGPT less than 3 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)

Renal:

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No other serious concurrent infection or other medical illness that would preclude study entry

• No frequent vomiting or partial bowel obstruction

• HIV negative

• No AIDS-related illness

• No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent epoetin alfa

Chemotherapy:

• At least 6 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)

Surgery:

• Recovered from prior surgery

Other:

• No other concurrent investigational agents

• Concurrent anticonvulsant therapy allowed

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Neurological Clinic	Portland	Oregon
United States	Stanford University Medical Center	Stanford	California
United States	Nalitt Institute for Cancer And Blood Related Diseases	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center

Country where clinical trial is conducted

United States,