NCT00082914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 20, 2013

Status Verified

December 1, 2005

First QC Date

May 14, 2004

Last Update Submit

June 18, 2013

Conditions

Kidney CancerMelanoma (Skin)

Keywords

recurrent renal cell cancerstage IV renal cell cancerrecurrent melanomastage IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Clinical response

Secondary Outcomes (2)

  • Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood

  • Toxicity

Interventions

denileukin diftitoxBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsMelanomaCarcinoma, Renal Cell

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • Steven A. Rosenberg, MD, PhD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

March 1, 2004

Study Completion

July 1, 2006

Last Updated

June 20, 2013

Record last verified: 2005-12

Locations

US(2)