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Home > "F" Clinical Trials Conditions > Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer  Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
For Condition: Melanoma,Renal Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The purpose of this study is to find the largest dose of CD40 L that can be given safely with Flt3L in patients with kidney cancer or metastatic melanoma (melanoma that has spread beyond the original site). Each drug alone has been used safely, but the two have not been used in combination before this study. Flt3L increases the number of a type of immune cell called dendritic cells, which are known to enhance the immune response. CD40L works to activate the response of these cells. Patients 16 years of age and older with metastatic melanoma or kidney cancer that cannot be cured with conventional treatments such as surgery, radiation therapy and chemotherapy may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests, chest X-ray, electrocardiogram, and X-rays and scans to evaluate disease status. Participants will have an injection of Flt3L under the skin every day for 14 days. (Patients or a caregiver will be taught how to administer the injections.) On the 12th day of treatment, patients will also begin receiving CD40L under the skin, for 5 days. If the patients starting at this lowest dose of CD40L do not experience any significant side effects, the dose will be increased for the next group of patients. The dose will be increased a third time if patients in the second group do not have significant side effects. The treatment cycle may be repeated after 28 days from the start of the injections. Patients will undergo leukapheresis to collect white blood cells before beginning treatment and again around day 17. For this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body through a second needle placed in the other arm. Patients will be evaluated with a physical examination, X-rays and scans after two cycles for the response to treatment. Patients whose tumors shrink and patients with a mixed response (i.e., some tumors shrink and others enlarge) may be offered up to a total of 6 treatment cycles. Patients whose disease remains stable or worsens will stop Flt3L and CD40 and may be offered treatment with interleukin-2, a substance that may boost the body's immune response to the tumor. Patients will have frequent blood tests. Some patients may have a skin biopsy to evaluate the effects of Flt3L and CD40L. For the biopsy, a small area of skin is numbed with an anesthetic and less than one-quarter inch of skin is removed for study under the microscope.
Details: Patients with metastatic melanoma and renal cell cancer will be treated with a combination of Flt3L and CD40L. The maximum tolerated dose of CD40L in combination with a fixed dose of Flt3L will be determined.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with metastatic renal cell cancer and metastatic melanoma with disease that is measurable and an expected survival of greater than three months. Any patient 16 years old or greater. Serum creatinine of 2.0 mg/dl or less. Bilirubin 1.6 mg/dl or less. WBC 3000/mm(3) or greater. Platelet count 90,000 mm(3) or greater. Serum AST/ALT less than 2.5 times normal. ECOG performance status of 0 or 1. Patients must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery or localized radiation for their cancer. Patients must not have active systemic infections, coagulation disorders, history of autoimmune disorders or other major active medical illnesses of the cardiovascular or respiratory systems. Patients must not require systemic steroid therapy. Patients must not be pregnant (because of possible side effects on the fetus) and/or breast feeding. Patients must not be positive for hepatitis BsAg, or HIV antibody (because of possible immune effects of these conditions). Patients who have had prior systemic therapy with Flt3L or CD40L will be excluded. Patients who will receive IL-2 as part of this protocol must be eligible to receive IL-2 including no active major medical illnesses such as cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. Any patient receiving IL-2 must be willing to execute a durable power of attorney (DPA).
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010121; 01-C-0121
Study Start Date: March 8, 2001
Record last reviewed: December 21, 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012532
Other Renal Cancer Studies:
1. Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
Related Studies:
Other Renal Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
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