Prolonged Daily Temozolomide for Low-Grade Glioma

Glioma Clinical Trial

Official title:

A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165360
• Other study ID #: 01-111
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: October 30, 2009
• Start date: September 2001
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2009
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Glioma
• Oligodendroglioma

Intervention

Drug:
• Temozolomide
Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Schering-Plough, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effects temozolomide has on low-grade gliomas		3 years	No
Secondary	To determine whether temozolomide is effective in preventing or delaying future tumor growth		3 years	No
Secondary	to determine the safety of temozolomide		3 years	Yes