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


Phase 2
16 Years
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin)

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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 SupportBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892