Completed

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

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+21

+ Adenocarcinoma
+ Carcinoma
Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer 
NCT00078702NCT00082914
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 16 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Adenocarcinoma
Carcinoma
Carcinoma, Renal Cell
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Kidney Neoplasms
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
Female Urogenital Diseases
Male Urogenital Diseases
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location
Suspended
NCI - Center for Cancer ResearchBethesda, United States

Completed2 Study Centers
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