Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer; Melanoma (Skin)

• Registration Number: NCT00082914
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-18
• Study First Posted: 2004-05-19
• Status Verified: 2005-12
• Study Completion: 2006-07
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response

Secondary Outcome Measures

Name	Time	Method
Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
Toxicity

Trial Locations

Locations (2)

NCI - Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States