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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00082914

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer Melanoma (Skin)	Biological: denileukin diftitox	Phase 2

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 Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Clinical response []

Secondary Outcome Measures

Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
2	NCI - Center for Cancer Research	Bethesda	Maryland	United States	20892