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Temozolomide in Treating Patients With Low-Grade Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00313729
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Procedure: adjuvant therapy
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 1999
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

  • Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
  • Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

    • Oligodendroglioma
    • Astrocytoma
    • Oligoastrocytoma
  • Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

    • Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
  • Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • BUN < 1.5 times ULN
  • Bilirubin < 1.5 times ULN
  • SGOT < 2.5 times ULN
  • Alkaline phosphatase < 2 times ULN
  • Life expectancy > 12 weeks
  • No nonmalignant systemic disease resulting in the patient being a poor medical risk
  • No acute infection requiring intravenous antibiotics
  • No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

    • Prior malignancies must be in remission for ≥ 5 years
  • No known HIV positivity
  • No AIDS-related illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
  • No prior biological therapy or chemotherapy for low-grade glioma
  • No other concurrent chemotherapy
  • No concurrent radiotherapy or biological therapy
  • No concurrent prophylactic growth factors
  • No concurrent epoetin alfa
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313729

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Study Chair: Susan M. Chang, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: UCSF Medical Center at Parnassus ( Susan Marina Chang )
Study ID Numbers: CDR0000448883, UCSF-99102, BTRC-9902, UCSF-H7858-16278-07
Study First Received: April 11, 2006
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00313729  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult oligodendroglioma
adult mixed glioma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineal gland astrocytoma

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

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

ClinicalTrials.gov processed this record on January 16, 2009