Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
- Determine the clinical response in patients with metastatic melanoma or metastatic
kidney cancer treated with denileukin diftitox.
- Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in
the peripheral blood of these patients before and after treatment with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: Patients are stratified according to disease type (metastatic melanoma vs
metastatic kidney cancer).
Patients receive denileukin diftitox IV over 1 hour on days 1-5, 21-25, 42-46, and 63-67.
Treatment repeats every 84 days (12 weeks) for up to a maximum total of 5 courses in the
absence of disease progression, autoimmune ocular toxicity attributable to denileukin
diftitox, or any other unacceptable toxicity. At any time during therapy, patients achieving
a complete response receive 1 additional course of therapy after the complete response.
PROJECTED ACCRUAL: A total of 10-96 patients (5-48 per stratum) will be accrued for this
study within 3-4 years.
Masking: Open Label, Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|