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Prolonged Daily Temozolomide for Low-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00165360
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 2, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Glioma Astrocytoma Oligodendroglioma Drug: Temozolomide Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
Study Start Date : September 2001
Primary Completion Date : December 2006
Study Completion Date : September 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. To determine the effects temozolomide has on low-grade gliomas [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To determine whether temozolomide is effective in preventing or delaying future tumor growth [ Time Frame: 3 years ]
  2. to determine the safety of temozolomide [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165360

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
University of Virginia
Principal Investigator: Patrick Wen, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Patrick Wen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165360     History of Changes
Other Study ID Numbers: 01-111
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Dana-Farber Cancer Institute:
low-grade glioma
mixed oligoastrocytoma

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents