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Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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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 CenterCleveland, Ohio  44106-5065