Clinical trial NCT00165360: Prolonged Daily Temozolomide for Low-Grade Glioma
Official title: A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Astrocytoma
Oligodendroglioma
Keywords: low-grade glioma
astrocytoma
oligodendroglioma
oligoastrocytoma
temozolomide
mixed oligoastrocytoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Schering-Plough
name: Brigham and Women's Hospital
name: University of Virginia
First posted: 2005-09-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To determine the effects temozolomide has on low-grade gliomas
timeFrame: 3 years
Secondary outcomes:
measure: To determine whether temozolomide is effective in preventing or delaying future tumor growth
timeFrame: 3 years
measure: to determine the safety of temozolomide
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Patrick Wen, MD
role: PRINCIPAL_INVESTIGATOR
References: