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

Primary Purpose

Central Nervous System Tumors, Brain Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Tumors focused on measuring adult anaplastic oligodendroglioma, adult mixed glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide

Arm Description

Temozolomide, 150 mg/m2/d x days 1-7 and 15-21

Outcomes

Primary Outcome Measures

Progression-Free Survival
Time in months to patient's disease progresses

Secondary Outcome Measures

Toxicity--Count of Related Advers Events
Count of Treatment Related Toxicities

Full Information

First Posted
November 16, 2006
Last Updated
September 14, 2018
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00400816
Brief Title
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Official Title
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
January 17, 2008 (Actual)
Study Completion Date
January 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Tumors, Brain Tumor
Keywords
adult anaplastic oligodendroglioma, adult mixed glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
Temozolomide, 150 mg/m2/d x days 1-7 and 15-21
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
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]
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Time in months to patient's disease progresses
Time Frame
Survival of Last Patient
Secondary Outcome Measure Information:
Title
Toxicity--Count of Related Advers Events
Description
Count of Treatment Related Toxicities
Time Frame
Post-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Peereboom, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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