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Prolonged Daily Temozolomide for Low-Grade Glioma

Primary Purpose

Glioma, Astrocytoma, Oligodendroglioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring low-grade glioma, astrocytoma, oligodendroglioma, oligoastrocytoma, temozolomide, mixed oligoastrocytoma

Eligibility Criteria

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

Inclusion Criteria: Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) Measurable disease on MRI Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery. Patients with recurrent disease my have had one prior chemotherapy regimen Older than 18 years of age. Karnofsky performance status (KPS) performance score of > 70% Adequate hematologic, renal and liver functions, Life expectancy of greater than 12 weeks. Negative pregnancy test. Exclusion Criteria: Prior treatment with temozolomide Patients who are not neurologically stable Acute infection treated with intravenous antibiotics Non-malignant systemic disease Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication. Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin. HIV positive or AIDS-related illness Pregnant or nursing women Patients with allergy to decarbazine.

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To determine the effects temozolomide has on low-grade gliomas

Secondary Outcome Measures

To determine whether temozolomide is effective in preventing or delaying future tumor growth
to determine the safety of temozolomide

Full Information

First Posted
September 9, 2005
Last Updated
October 30, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Schering-Plough, Brigham and Women's Hospital, University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00165360
Brief Title
Prolonged Daily Temozolomide for Low-Grade Glioma
Official Title
A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Schering-Plough, Brigham and Women's Hospital, University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
Detailed Description
Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide. Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment). Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Astrocytoma, Oligodendroglioma
Keywords
low-grade glioma, astrocytoma, oligodendroglioma, oligoastrocytoma, temozolomide, mixed oligoastrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half
Primary Outcome Measure Information:
Title
To determine the effects temozolomide has on low-grade gliomas
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To determine whether temozolomide is effective in preventing or delaying future tumor growth
Time Frame
3 years
Title
to determine the safety of temozolomide
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) Measurable disease on MRI Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery. Patients with recurrent disease my have had one prior chemotherapy regimen Older than 18 years of age. Karnofsky performance status (KPS) performance score of > 70% Adequate hematologic, renal and liver functions, Life expectancy of greater than 12 weeks. Negative pregnancy test. Exclusion Criteria: Prior treatment with temozolomide Patients who are not neurologically stable Acute infection treated with intravenous antibiotics Non-malignant systemic disease Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication. Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin. HIV positive or AIDS-related illness Pregnant or nursing women Patients with allergy to decarbazine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wen, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prolonged Daily Temozolomide for Low-Grade Glioma

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