A Phase I Trial of Weekly 17-Allylamino-17 Demethoxygeldanamycin
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity and maximum tolerated dose of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial
cancer, malignant lymphoma, or sarcoma.
II. Determine the significant toxic effects associated with this drug in these patients.
III. Determine the response in patients treated with this drug. IV. Determine the
pharmacokinetics of 17-AAG and 17AG in these patients.
OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2
schedules.
Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2
hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses
repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
In both schedules, cohorts of 3-6 patients receive escalating doses of 17-AAG 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. At least 6 patients receive
treatment at the MTD.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT) assessed using Common Toxicity Criteria version 2.0
4 weeks
Yes
Ramesh Ramanathan
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
NCI-2012-02315
NCT00004241
October 1999
Name | Location |
|---|---|
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
