Prolonged Daily Temozolomide for Low-Grade Glioma
A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
1 other identifier
interventional
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2001
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 2, 2009
October 1, 2009
5.3 years
September 9, 2005
October 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effects temozolomide has on low-grade gliomas
3 years
Secondary Outcomes (2)
To determine whether temozolomide is effective in preventing or delaying future tumor growth
3 years
to determine the safety of temozolomide
3 years
Interventions
Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Schering-Ploughcollaborator
- Brigham and Women's Hospitalcollaborator
- University of Virginiacollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Wen, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
September 1, 2001
Primary Completion
December 1, 2006
Study Completion
September 1, 2009
Last Updated
November 2, 2009
Record last verified: 2009-10