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A Phase II Trial of Irinotecan in Recurrent Glioma

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

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Trial Information

A Phase II Trial of Irinotecan in Recurrent Glioma

OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with
recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate
the pharmacological parameters with toxicity and response to therapy.

OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea
administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any
time. Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1, 8, 15, and
22. This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients
assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients
in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan.
The dosages may be increased once per patient after the first course if toxic effects are
acceptable. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3
months for the first year, every 6 months for the next 4 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 30 patients in each treatment arm in 24 months,
for a total of 60 patients.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven primary brain glioma Astrocytoma
Gliosarcoma Oligodendroglioma Oligoastrocytoma Tumor progression by CT scan or MRI
following radiotherapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at
least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL
AST no greater than 3 times upper limit of normal No prior Gilbert's syndrome Renal:
Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of myocardial infarction
within 6 months No congestive heart failure requiring therapy Other: No concurrent active
second malignancy No uncontrolled infection No other severe concurrent disease Not
pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior adjuvant chemotherapy regimen and 1 for recurrence (Gliadel is considered 1 regimen)
At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas No
prior irinotecan, topotecan, or aminocamptothecin Endocrine therapy: At least 2 weeks on
fixed dose of corticosteroids (or no corticosteroids) prior to baseline scan Radiotherapy:
At least 8 weeks since prior radiotherapy Surgery: No surgical resection between last
radiotherapy or chemotherapy and study therapy, unless unequivocal tumor growth since

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jan C. Buckner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult brain stem glioma
  • adult oligodendroglioma
  • adult mixed glioma
  • adult diffuse astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080