A Phase I Trial of 17-Allylaminogeldanamycin (17-AAG) in Solid Tumor and Lymphoma Patients
- Determine the maximum tolerated dose and dose-limiting toxicity of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG), administered at 2 different dosing
schedules, in patients with unresectable solid tumors.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the effect of this drug on heat shock protein chaperone complex components and
client proteins in lymphoma tissue obtained pre- and post-treatment in patients with
- Determine any response to this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1
hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
- Group II: Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 solid tumor 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.
Once the MTD is determined, 10 patients with either lymphoma or superficial solid tumors
accessible for biopsy are treated as in group II at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 58-130 patients (30-72 for group I and 28-58 for group II)
will be accrued for this study within 2 years.
Primary Purpose: Treatment
Charles Erlichman, MD
United States: Federal Government
|Mayo Clinic||Rochester, Minnesota 55905|