Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00400816
First received: November 16, 2006
Last updated: May 13, 2011
Last verified: January 2007
  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 newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
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: Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Survival of Last Patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2005
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: temozolomide
    Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]
    Other Name: Temodar
Detailed Description:

OBJECTIVES:

  • Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
  • Determine the response rate in these patients.
  • Assess the quality of life of patients with AO or MOA treated with this regimen.

OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 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 confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:

    • Bidimensionally measurable disease
    • Evaluable disease
    • Nonevaluable disease as demonstrated by gross total surgical resection
  • No immediate need for cranial irradiation

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.0 times ULN
  • AST ≤ 3.0 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No infection requiring systemic antibiotics within the past 14 days
  • No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No unrelated medical problems that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for this malignancy
  • No prior radiotherapy to the brain
  • No surgery requiring general anesthesia > 2 hours in duration within the past 10 days
  • No prior temozolomide
  • Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry
  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: NCT00400816

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: David M. Peereboom, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cleveland Clinic Foundation, David Peereboom, MD
ClinicalTrials.gov Identifier: NCT00400816     History of Changes
Other Study ID Numbers: CASE-CCF-4204, P30-CA43703
Study First Received: November 16, 2006
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
adult anaplastic oligodendroglioma
adult mixed glioma

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

ClinicalTrials.gov processed this record on September 30, 2014