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Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Sponsored by
Herbert Irving Comprehensive Cancer Center
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 anaplastic astrocytoma, adult anaplastic oligodendroglioma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven recurrent or progressive malignant glioma of one of the following types: Anaplastic oligodendroglioma or oligoastrocytoma Anaplastic astrocytoma Glioblastoma multiforme (stratum closed to accrual 11/30/01) Patients who have failed radiotherapy are eligible Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: SGOT or SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed) Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No other serious concurrent infection or other medical illness that would preclude study entry No frequent vomiting or partial bowel obstruction HIV negative No AIDS-related illness No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent epoetin alfa Chemotherapy: At least 6 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator) Surgery: Recovered from prior surgery Other: No other concurrent investigational agents Concurrent anticonvulsant therapy allowed

Sites / Locations

  • Stanford University Medical Center
  • Mount Sinai Comprehensive Cancer Center
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Cancer Center of Albany Medical Center
  • Herbert Irving Comprehensive Cancer Center
  • Nalitt Institute for Cancer And Blood Related Diseases
  • Cleveland Clinic Taussig Cancer Center
  • Neurological Clinic
  • University of Pennsylvania Cancer Center
  • Froedtert Memorial Lutheran Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2000
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00004204
Brief Title
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Official Title
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center

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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.
Detailed Description
OBJECTIVES: Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide. Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide. Determine the toxicity of this regimen in these patients. OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

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 anaplastic astrocytoma, adult anaplastic oligodendroglioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

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 proven recurrent or progressive malignant glioma of one of the following types: Anaplastic oligodendroglioma or oligoastrocytoma Anaplastic astrocytoma Glioblastoma multiforme (stratum closed to accrual 11/30/01) Patients who have failed radiotherapy are eligible Measurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10 g/dL Hepatic: SGOT or SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed) Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No other serious concurrent infection or other medical illness that would preclude study entry No frequent vomiting or partial bowel obstruction HIV negative No AIDS-related illness No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent epoetin alfa Chemotherapy: At least 6 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator) Surgery: Recovered from prior surgery Other: No other concurrent investigational agents Concurrent anticonvulsant therapy allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casilda Balmaceda, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nalitt Institute for Cancer And Blood Related Diseases
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurological Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

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