Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer|
- Clinical response [ Designated as safety issue: No ]
- Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
|Study Completion Date:||July 2006|
- 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.
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|