- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005951
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Temozolomide
- Irinotecan
Other Study ID Numbers
- 1087
- DUMC-1087-02-6R3
- DUMC-001087-006R1
- DUMC-1067-99-6
- NCI-G00-1795
- DUMC-001087-01-6R2
- CDR0000067931
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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