Trials / Completed
CompletedNCT00082914
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | denileukin diftitox |
Timeline
- Start date
- 2004-03-01
- Completion
- 2006-07-01
- First posted
- 2004-05-19
- Last updated
- 2013-06-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00082914. Inclusion in this directory is not an endorsement.