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Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal


OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed,
progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this
drug in this patient population.

OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed
anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients
receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients
with progressive or recurrent disease (at baseline) continue treatment in the absence of
disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue
treatment for a maximum of 4 courses before radiotherapy in the absence of disease
progression or unacceptable toxicity. Patients with responding disease may receive an
additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study
treatment.) Patients are followed every 8 weeks for 2 years.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic
oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy
Newly diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At
least 1.5 cm2 by MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5
times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase
less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times
ULN Other: Neurologically stable No nonmalignant systemic disease No acute infection
treated with intravenous antibiotics No frequent vomiting No medical condition (e.g.,
partial bowel obstruction) that would interfere with oral medication intake No other prior
or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal
cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No
concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa)
Chemotherapy: No more than 1 prior chemotherapy regimen No other concurrent chemotherapy
Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study
Concurrent steroids allowed Radiotherapy: See Disease Characteristics No concurrent
radiotherapy Surgery: At least 2 weeks since prior surgical resection (newly diagnosed
patients must be enrolled within 28 days of surgery or biopsy) Recovered from prior major
surgery Other: No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

1534

NCT ID:

NCT00003465

Start Date:

March 1998

Completion Date:

February 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic oligodendroglioma
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710