Temozolomide in Treating Patients With Progressive Low-Grade Glioma

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00003466

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide	Phase 2

Detailed Description

OBJECTIVES:

Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.

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

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Primary Purpose:

Treatment

Official Title:

Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Response rate []
Activity of temozolomide []

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
Astrocytoma
Oligodendroglioma
Mixed glioma
Optic pathway glioma*
Pontine glioma* NOTE: *Biopsy not required
Patients with optic pathway glioma must also meet the following criteria:
Progressive loss of vision as defined by doubling of octaves
Visual acuity loss not explained by other causes
Increase in proptosis of greater than 3 mm
Increase in diameter of optic nerve of at least 2 mm on neuroimaging
Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

4 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

More than 12 weeks

Hematopoietic:

Absolute neutrophil count at least 1,500/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:

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

Other:

Must be neurologically stable
No systemic disease
No acute infection requiring IV antibiotics
No frequent vomiting
No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
No other prior or concurrent malignancies except:
Surgically cured carcinoma in situ of the cervix
Basal or squamous cell skin cancer
HIV negative
No AIDS-related illness
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent biologic therapy (growth factors or epoetin alfa)

Chemotherapy:

At least 6 weeks since prior chemotherapy unless evidence of disease progression
No other concurrent chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 6 weeks since prior radiotherapy unless evidence of disease progression
No concurrent radiotherapy

Surgery:

At least 3 weeks since prior surgery unless evidence of disease progression
Recovered from all prior surgery

Other:

No other concurrent investigational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
2	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4318