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Home > "D" Clinical Trials Conditions > Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer  Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,Recurrent Melanoma,Stage 4 Melanoma,stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have metastaticmelanoma or metastatic kidney cancer.
Details: 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 6 courses in the absence of disease progression, autoimmune ocular toxicity attributable to denileukin diftitox, or any other unacceptable toxicity. Patients achieving a complete response receive 1 additional course of therapy. PROJECTED ACCRUAL: A total of 42-86 patients (21-43 per stratum) will be accrued for this study within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenRosenberg, Study Chair, Surgery Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000361715; NCI-04-C-0134
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082914
Other Stage 4 Melanoma Studies:
1. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
2. Monoclonal Antibody With or Without Dacarbazine in Treating Patients With Unresectable Metastatic Melanoma
3. Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
4. Vaccine Therapy in Treating Patients With Stage IV Melanoma
5. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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