A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL
- Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in
patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell
- Determine if antitumor activity of this drug exists in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
- Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to
8 weeks in the absence of disease progression or unacceptable toxicity. Patients with
stable disease or complete or partial response after induction therapy proceed to
Cohorts of 6 patients receive escalating doses of alefacept 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. The optimal immunologic dose is defined as the dose that
does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2
- Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4
weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.
Patients who experience disease progression during maintenance therapy may receive
reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a
second maintenance phase in the absence of disease progression.
NOTE: *Only 1 reinduction allowed.
Patients undergo blood and tissue collection periodically for pharmacological studies. Blood
serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms,
and CD2 saturation via flow cytometry.
After completion of study treatment, patients are followed every 3 months for up to 3 years
and then periodically thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
9/21/2006 - 7/06/2010
Thomas E. Witzig, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|