Temozolomide in Treating Patients With Progressive Low-Grade Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00003466
First received: November 1, 1999
Last updated: July 7, 2014
Last verified: February 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Activity of temozolomide [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 1998
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
  • Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:

    • Astrocytoma
    • Oligodendroglioma
    • Mixed glioma
    • Optic pathway glioma*
    • Pontine glioma* NOTE: *Biopsy not required
  • Patients with optic pathway glioma must also meet the following criteria:

    • Progressive loss of vision as defined by doubling of octaves
    • Visual acuity loss not explained by other causes
    • Increase in proptosis of greater than 3 mm
    • Increase in diameter of optic nerve of at least 2 mm on neuroimaging
    • Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 4 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN

Renal:

  • Creatinine less than 1.5 times ULN
  • BUN less than 1.5 times ULN

Other:

  • Must be neurologically stable
  • No systemic disease
  • No acute infection requiring IV antibiotics
  • No frequent vomiting
  • No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except:

    • Surgically cured carcinoma in situ of the cervix
    • Basal or squamous cell skin cancer
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy (growth factors or epoetin alfa)

Chemotherapy:

  • At least 6 weeks since prior chemotherapy unless evidence of disease progression
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 6 weeks since prior radiotherapy unless evidence of disease progression
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior surgery unless evidence of disease progression
  • Recovered from all prior surgery

Other:

  • No other concurrent investigational drugs
  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: NCT00003466

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00003466     History of Changes
Other Study ID Numbers: 1703 (CDR0000066502), DUMC-1703-04-12R7, DUMC-000693-01-3R1, DUMC-1703-01-94R, DUMC-1502-97-10, DUMC-1569-98-10R1, DUMC-97125, NCI-G98-1469, DUMC-1703-02-9R5
Study First Received: November 1, 1999
Last Updated: July 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
recurrent adult brain tumor
adult mixed glioma
childhood mixed glioma
adult pilocytic astrocytoma
adult subependymoma
recurrent childhood cerebral astrocytoma
adult brain stem glioma
recurrent childhood brain stem glioma
untreated childhood brain stem glioma
recurrent childhood visual pathway and hypothalamic glioma
untreated childhood visual pathway and hypothalamic glioma
adult oligodendroglioma
adult diffuse astrocytoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014