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

Kidney Cancer Clinical Trial

Official title:

Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082914
• Other study ID #: CDR0000361715
• Secondary ID: NCI-04-C-0134
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: June 18, 2013
• Start date: March 2004
• Est. completion date: July 2006

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00078702

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Melanoma

• Kidney cancer

• Metastatic disease

• Measurable disease

• Documented disease progression while receiving standard therapy

• No resectable local or regional disease

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC = 3,000/mm^3

• Platelet count = 90,000/mm^3

• Lymphocyte count = 500/mm^3

• No concurrent coagulation disorders

Hepatic

• Bilirubin = 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)

• AST and ALT < 3 times normal

• Albumin = 2.5 g/dL

• Hepatitis B surface antigen negative

• Hepatitis C antibody negative

Renal

• Creatinine = 2.0 mg/dL

Cardiovascular

• Normal thallium stress test*

• No prior myocardial infarction

• No history of severe coronary artery disease

• No major medical illness of the cardiovascular system NOTE: *For patients > 50 years of age OR who have a history of cardiovascular disease

Pulmonary

• No major medical illness of the respiratory system

Immunologic

• HIV negative

• No active systemic infection

• No presence of opportunistic infections

• No primary or secondary immunodeficiency

• No autoimmune disease

• No other known immunodeficiency

Other

• No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients)

• Willing to undergo leukapheresis

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy

Chemotherapy

• Recovered from prior chemotherapy

Endocrine therapy

• No concurrent systemic steroids

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• More than 3 weeks since prior systemic anticancer therapy

• No other concurrent systemic anticancer therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• denileukin diftitox

Locations

Country	Name	City	State
United States	NCI - Center for Cancer Research	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response			No
Secondary	Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood			No
Secondary	Toxicity			Yes