A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
- Determine the safety and tolerability of monoclonal antibody HuM291 in patients with
advanced or recurrent CD3+ T-cell lymphomas.
- Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this
- Determine the response in these patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of
unacceptable toxicity. Patients achieving a partial response, complete response with
recurrence, or stable disease may receive further therapy.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6
patients experience dose-limiting toxicity.
Patients are followed weekly for 1 month and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
Primary Purpose: Treatment
Youn H. Kim, MD
United States: Federal Government
|Stanford University Medical Center||Stanford, California 94305-5408|