First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial


Phase 2
18 Years
70 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial


OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in
patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the
objective response and duration of response of these patients given this treatment. III.
Characterize the acute side effects of temozolomide in this patient population.

OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on
days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12
courses in the absence of unacceptable toxicity or disease progression. Patients are
followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma with
at least 25% oligodendroglial elements Recurrent or progressive disease following
radiotherapy At least 3 months since prior radiotherapy Measurable disease by MRI or CT
scan Lesion must have a diameter of at least 1 cm No progressive neurological deficits
from the present recurrence No new neurological deficits interfering with daily activities
No tumor causing midline shift or brain stem compression due to which a rapid
deterioration is to be expected in case of no response No signs of increased intracranial
pressure No extracranial disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN)
AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN
Renal: Creatinine clearance at least 60 mL/min Creatinine no greater than 1.25 times ULN
Neurologic: See Disease Characteristics Other: Not pregnant or nursing Fertile patients
must use effective contraception No other malignant or nonmalignant diseases interfering
with follow-up No psychological, familial, sociological, or geographical condition
potentially hampering compliance with the study and follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: Not specified Other: No other concurrent investigational drugs No other
concurrent antitumor agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin J. van Den Bent, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-26971

NCT ID:

NCT00003731

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult oligodendroglioma
  • adult mixed glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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