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Prolonged Daily Temozolomide for Low-Grade Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Schering-Plough
Brigham and Women's Hospital
University of Virginia
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165360
  Purpose

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 Intervention Phase
Glioma
Astrocytoma
Oligodendroglioma
Drug: Temozolomide
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the effects temozolomide has on low-grade gliomas [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether temozolomide is effective in preventing or delaying future tumor growth [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • to determine the safety of temozolomide [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:   46
Study Start Date:   September 2001
Estimated Study Completion Date:   December 2009
Primary Completion Date:   December 2006 (Final data collection date for primary outcome measure)

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
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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165360

Locations
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital    
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators
Dana-Farber Cancer Institute
Schering-Plough
Brigham and Women's Hospital
University of Virginia

Investigators
Principal Investigator:     Patrick Wen, MD     Dana-Farber Cancer Institute    
  More Information


Responsible Party:   Dana-Farber Cancer Institute ( Patrick Wen, MD )
Study ID Numbers:   01-111
First Received:   September 9, 2005
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00165360
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Neuroectodermal Tumors
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Temozolomide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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