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Temozolomide in Treating Patients With Low-Grade Glioma

Primary Purpose

CNS Tumor, Adult

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CNS Tumor, Adult focused on measuring adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: Oligodendroglioma Astrocytoma Oligoastrocytoma Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma Study treatment must begin between 14 days and 4 months after surgical resection or biopsy Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine < 1.5 times upper limit of normal (ULN) BUN < 1.5 times ULN Bilirubin < 1.5 times ULN SGOT < 2.5 times ULN Alkaline phosphatase < 2 times ULN Life expectancy > 12 weeks No nonmalignant systemic disease resulting in the patient being a poor medical risk No acute infection requiring intravenous antibiotics No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin Prior malignancies must be in remission for ≥ 5 years No known HIV positivity No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma No prior biological therapy or chemotherapy for low-grade glioma No other concurrent chemotherapy No concurrent radiotherapy or biological therapy No concurrent prophylactic growth factors No concurrent epoetin alfa No other concurrent investigational drugs

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide

Arm Description

Temozolomide

Outcomes

Primary Outcome Measures

Response Rate (Complete and Partial Response)
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.

Secondary Outcome Measures

Time to Tumor Progression
Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
Safety Profile
Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0

Full Information

First Posted
April 11, 2006
Last Updated
January 22, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00313729
Brief Title
Temozolomide in Treating Patients With Low-Grade Glioma
Official Title
A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
September 25, 2014 (Actual)
Study Completion Date
June 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
Detailed Description
OBJECTIVES: Primary Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma. Secondary Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma. Assess the time to tumor progression in patients treated with temozolomide. OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients 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
CNS Tumor, Adult
Keywords
adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult pineal gland astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
Temozolomide
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Response Rate (Complete and Partial Response)
Description
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to Tumor Progression
Description
Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
Time Frame
time from registration until date of the first documented progression, an average of 1 year
Title
Safety Profile
Description
Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
Time Frame
Time from registration up to 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: Oligodendroglioma Astrocytoma Oligoastrocytoma Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma Study treatment must begin between 14 days and 4 months after surgical resection or biopsy Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Creatinine < 1.5 times upper limit of normal (ULN) BUN < 1.5 times ULN Bilirubin < 1.5 times ULN SGOT < 2.5 times ULN Alkaline phosphatase < 2 times ULN Life expectancy > 12 weeks No nonmalignant systemic disease resulting in the patient being a poor medical risk No acute infection requiring intravenous antibiotics No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin Prior malignancies must be in remission for ≥ 5 years No known HIV positivity No AIDS-related illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma No prior biological therapy or chemotherapy for low-grade glioma No other concurrent chemotherapy No concurrent radiotherapy or biological therapy No concurrent prophylactic growth factors No concurrent epoetin alfa No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M. Chang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Temozolomide in Treating Patients With Low-Grade Glioma

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