Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma
I. Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients
with recurrent glioma.
II. Determine the toxic effects of this treatment regimen in these patients. III. Determine
the safety of this treatment regimen at the recommended phase II dose in patients not
IV. Determine the efficacy of this treatment regimen in these patients. V. Assess the
pharmacokinetics and metabolism of pyrazoloacridine in these patients.
VI. Assess the response rate, time to progression, and time to death in patients treated
with this regimen.
OUTLINE: This is a three-part, dose-escalation, multicenter study. Patients in study 3 are
stratified according to concurrent anticonvulsants (yes vs no).
STUDY 1: (Study 1 closed as of 03/29/02) Patients receive carboplatin IV over 30 minutes and
pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence
of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 6 patients experience dose-limiting toxicity.
STUDY 2: (Study 2 closed as of 03/29/02) Patients receive the same treatment as given in
study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not
receiving concurrent anticonvulsants.
STUDY 3: Patients receive the same treatment as given in studies 1 and 2 without dose
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually for 5 years.
Study 1: A total of 3-21 patients will be accrued for this study within 6-20 months.
Study 2: A total of 3-12 patients will be accrued for this study within 3-18 months.
Study 3: A total of 12-37 patients will be accrued for this study within 15 months.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evanthia Galanis, MD
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|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 - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|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|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|
|Altru Cancer Center||Grand Forks, North Dakota 58206|