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Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
temozolomide
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
August 20, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005951
Brief Title
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
Official Title
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Friedman, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

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