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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00165360
Other study ID # 01-111
Secondary ID
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


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
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