Prolonged Daily Temozolomide for Low-Grade Glioma

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Brigham and Women's Hospital
University of Virginia
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165360
First received: September 9, 2005
Last updated: October 30, 2009
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Resource links provided by NLM:


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
Study Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Schering-Plough
Brigham and Women's Hospital
University of Virginia
Investigators
Principal Investigator: Patrick Wen, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Patrick Wen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165360     History of Changes
Other Study ID Numbers: 01-111
Study First Received: September 9, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Oligodendroglioma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014