Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00005951

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: irinotecan hydrochloride Drug: temozolomide	Phase 1

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of irinotecan administered in combination with temozolomide in patients with recurrent primary malignant glioma.
Determine the toxicity of this combination therapy in these patients.

OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or none).

Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: Not specified

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed recurrent primary malignant glioma
Anaplastic astrocytoma
Glioblastoma multiforme
Anaplastic oligodendroglioma
Gliosarcoma
Anaplastic mixed oligoastrocytoma
Measurable disease by MRI or CT
No immediate radiotherapy required
Neurologically stable for at least 2 weeks prior to study

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

Greater 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:

Blood urea nitrogen and creatinine less than 1.5 times ULN

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No other nonmalignant systemic disease
No acute infection treated with IV antibiotics
No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction)
No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No more than 1 prior biologic therapy regimen

Chemotherapy:

No more than 1 prior chemotherapy regimen
At least 6 weeks since prior chemotherapy, unless evidence of disease progression
No prior failure of irinotecan or temozolomide