Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

NCT ID: NCT00005951

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2006-04-30

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.

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

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

temozolomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 6 weeks since prior radiotherapy, unless evidence of disease progression

Surgery:

• At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered

Other:

• No concurrent immunosuppressive agents

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-1087-02-6R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-001087-006R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-1067-99-6

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1795

Identifier Type: -

Identifier Source: secondary_id

DUMC-001087-01-6R2

Identifier Type: -

Identifier Source: secondary_id

CDR0000067931

Identifier Type: -

Identifier Source: secondary_id

1087

Identifier Type: -

Identifier Source: org_study_id