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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400816
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : September 18, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Central Nervous System Tumors Brain Tumor Drug: temozolomide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
Study Start Date : August 2005
Actual Primary Completion Date : January 17, 2008
Actual Study Completion Date : January 6, 2016

Arm Intervention/treatment
Experimental: Temozolomide
Temozolomide, 150 mg/m2/d x days 1-7 and 15-21
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

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Survival of Last Patient ]
    Time in months to patient's disease progresses

Secondary Outcome Measures :
  1. Toxicity--Count of Related Advers Events [ Time Frame: Post-Treatment ]
    Count of Treatment Related Toxicities

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400816

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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
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Study Chair: David M. Peereboom, MD Case Comprehensive Cancer Center

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Responsible Party: The Cleveland Clinic Identifier: NCT00400816    
Other Study ID Numbers: CASE-CCF-4204
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: January 2018
Keywords provided by The Cleveland Clinic:
adult anaplastic oligodendroglioma
adult mixed glioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents