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Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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 anaplastic oligodendroglioma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least 1.5 cm2 by MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Neurologically stable No nonmalignant systemic disease No acute infection treated with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy: No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No other concurrent investigational drugs

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 19, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003465
Brief Title
Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
Official Title
Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2001 (Actual)

3. Sponsor/Collaborators

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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma.
Detailed Description
OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this drug in this patient population. OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with progressive or recurrent disease (at baseline) continue treatment in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years. PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.

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 oligodendroglioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (Anticipated)

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 confirmed supratentorial anaplastic oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least 1.5 cm2 by MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Neurologically stable No nonmalignant systemic disease No acute infection treated with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy: No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Friedman, MD
Organizational Affiliation
Duke University
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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Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

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