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

NeuroTherapia, Inc. logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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