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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 2

Conditions: Central Nervous System Tumors; Brain Tumor

Treatments: Drug: temozolomide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00400816

CASE-CCF-4204

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Temozolomide

Experimental group

Description:

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

Treatment:

Drug: temozolomide