Temozolomide in Treating Patients With Low-Grade Glioma

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

CNS Tumor, Adult

Treatments

Drug: temozolomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00313729

CDR0000448883

BTRC-9902

99102 (Other Identifier)

H7858-16278-07 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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