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.
Interventional
Primary Purpose: Treatment
Jan C. Buckner, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000065900
NCT00003134
January 1998
Name | Location |
---|---|
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 |