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

Primary Purpose

Kidney Cancer, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
denileukin diftitox
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • NCI - Center for Cancer Research

Outcomes

Primary Outcome Measures

Clinical response

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2004
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00082914
Brief Title
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Official Title
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Melanoma (Skin)
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
denileukin diftitox
Primary Outcome Measure Information:
Title
Clinical response
Secondary Outcome Measure Information:
Title
Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Rosenberg, MD, PhD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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

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