Temozolomide in Treating Patients With Low-Grade Glioma

NCT ID: NCT00313729

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2017-06-12

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Detailed Description

OBJECTIVES:

Primary

• Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

• Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
• Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Conditions

CNS Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

Temozolomide

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

Chemotherapy

Interventions

temozolomide

Chemotherapy

Intervention Type: DRUG

Other Intervention Names

Temodar

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

• Oligodendroglioma
• Astrocytoma
• Oligoastrocytoma
• Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

• Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
• Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• Creatinine < 1.5 times upper limit of normal (ULN)
• BUN < 1.5 times ULN
• Bilirubin < 1.5 times ULN
• SGOT < 2.5 times ULN
• Alkaline phosphatase < 2 times ULN
• Life expectancy > 12 weeks
• No nonmalignant systemic disease resulting in the patient being a poor medical risk
• No acute infection requiring intravenous antibiotics
• No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
• No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

• Prior malignancies must be in remission for ≥ 5 years
• No known HIV positivity
• No AIDS-related illness
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
• No prior biological therapy or chemotherapy for low-grade glioma
• No other concurrent chemotherapy
• No concurrent radiotherapy or biological therapy
• No concurrent prophylactic growth factors
• No concurrent epoetin alfa
• No other concurrent investigational drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Susan Chang

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan M. Chang, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

99102

Identifier Type: OTHER

Identifier Source: secondary_id

BTRC-9902

Identifier Type: -

Identifier Source: secondary_id

H7858-16278-07

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000448883

Identifier Type: -

Identifier Source: org_study_id

NCT00187642

Identifier Type: -

Identifier Source: nct_alias