search
Back to results

Temozolomide in Treating Patients With Progressive Low-Grade Glioma

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 mixed glioma, childhood mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood cerebral astrocytoma, adult brain stem glioma, recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma, adult oligodendroglioma, adult diffuse astrocytoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: Astrocytoma Oligodendroglioma Mixed glioma Optic pathway glioma* Pontine glioma* NOTE: *Biopsy not required Patients with optic pathway glioma must also meet the following criteria: Progressive loss of vision as defined by doubling of octaves Visual acuity loss not explained by other causes Increase in proptosis of greater than 3 mm Increase in diameter of optic nerve of at least 2 mm on neuroimaging Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: 4 and over Performance status: Karnofsky 70-100% Life expectancy: More 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: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring IV antibiotics No frequent vomiting No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) No other prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: At least 6 weeks since prior chemotherapy unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery unless evidence of disease progression Recovered from all prior surgery Other: No other concurrent investigational drugs

Sites / Locations

  • Duke Comprehensive Cancer Center
  • Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

Response rate
Activity of temozolomide

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 7, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003466
Brief Title
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Official Title
Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

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: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
Detailed Description
OBJECTIVES: Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide. Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) 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 mixed glioma, childhood mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood cerebral astrocytoma, adult brain stem glioma, recurrent childhood brain stem glioma, untreated childhood brain stem glioma, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma, adult oligodendroglioma, adult diffuse astrocytoma

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Primary Outcome Measure Information:
Title
Response rate
Title
Activity of temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: Astrocytoma Oligodendroglioma Mixed glioma Optic pathway glioma* Pontine glioma* NOTE: *Biopsy not required Patients with optic pathway glioma must also meet the following criteria: Progressive loss of vision as defined by doubling of octaves Visual acuity loss not explained by other causes Increase in proptosis of greater than 3 mm Increase in diameter of optic nerve of at least 2 mm on neuroimaging Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: 4 and over Performance status: Karnofsky 70-100% Life expectancy: More 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: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring IV antibiotics No frequent vomiting No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) No other prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: At least 6 weeks since prior chemotherapy unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery unless evidence of disease progression Recovered from all prior surgery Other: No other concurrent investigational drugs
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
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Temozolomide in Treating Patients With Progressive Low-Grade Glioma

We'll reach out to this number within 24 hrs