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Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer



Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

For Condition: stage 4 renal cell cancer,recurrent renal cell cancer,Stage 4 Melanoma,Recurrent Melanoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to stimulate the immune system and stop cancer cells from growing. Biological therapy may be an effective treatment for metastatic melanoma and metastatic kidney cancer. PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in treating patients who have metastatic melanoma or metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer. PROTOCOL OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3 ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16. Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2 (IL-2) standard therapy. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 1 year.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell cancer or melanoma - Measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic therapy; No prior systemic flt3 ligand or CD40-ligand - Chemotherapy: At least 3 weeks since prior chemotherapy - Endocrine therapy: At least 3 weeks since prior endocrine therapy; No concurrent systemic steroids - Radiotherapy: Prior localized radiotherapy for renal cell cancer or melanoma allowed - Surgery: Prior surgery for renal cell cancer or melanoma allowed --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-1 - Life expectancy: More than 3 months - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 90,000/mm3; No coagulation disorders - Hepatic: Bilirubin no greater than 1.6 mg/dL; AST and ALT less than 2.5 times normal; Hepatitis B surface antigen negative - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No major active medical illness of the cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac arrhythmia) - Pulmonary: No major active medical illness of the respiratory system (e.g., obstructive or restrictive pulmonary disease) - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active systemic infections; No history of autoimmune disorders; HIV negative
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatrickHwu,  Study Chair,  National Cancer Institute (NCI)

Surgery Branch
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  CDR0000068601;  NCI-01-C-0121,NCI-1035
Study Start Date: March 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020540

Other Stage 4 Melanoma Studies:
1. E7070 in Treating Patients With Stage IV Melanoma

2. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma

3. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma

4. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma

5. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

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