Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival
Outcome Time Frame:
Survival of Last Patient
Safety Issue:
No
Principal Investigator
David M. Peereboom, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE-CCF-4204
NCT ID:
NCT00400816
Start Date:
August 2005
Completion Date:
December 2011
Related Keywords:
- Brain and Central Nervous System Tumors
- adult anaplastic oligodendroglioma
- adult mixed glioma
- Nervous System Neoplasms
- Oligodendroglioma
- Central Nervous System Neoplasms
- Astrocytoma
Name | Location |
|---|---|
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
