Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: Primary * Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox. Secondary * 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.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
