Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
16 Years
N/A
Both
Kidney Cancer, Melanoma (Skin)
Trial Information
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response
Safety Issue:
No
Principal Investigator
Steven A. Rosenberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Federal Government
Study ID:
CDR0000361715
NCT ID:
NCT00082914
Start Date:
March 2004
Completion Date:
July 2006
Related Keywords:
- Kidney Cancer
- Melanoma (Skin)
- recurrent renal cell cancer
- stage IV renal cell cancer
- recurrent melanoma
- stage IV melanoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
| NCI - Center for Cancer Research | Bethesda, Maryland 20892 |
