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The Role of Peptide-Loaded Dendritic Cells to Augment the Therapeutic Effect of Interleukin-2
Basic Trial Information
Summary Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens. The principal objective of the study is to identify whether a dendritic cell-based vaccine can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be administered every 14 days by intra-lymph node injections, followed by high dose IL-2 treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months intervals. In a second group, patients will receive the standard high dose IL-2 protocol within a comparable period of time. Each group will include 12 patients. A complete evaluation of evaluable lesions will be performed prior to accrual, after initial 3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6 weeks after second cycle of IL-2 treatment. Eligibility Criteria Inclusion Criteria: 1. Any patient age 18 to 65, with measurable metastatic melanoma who has an expected survival of greater than three months. All patients will be HLA-A2 positive
2. serum creatinine of 2.0 mg/dl or less, 3. Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 4. WBC 3000/mm3 or greater 5. platelet count 90,000 mm3 or greater 6. serum AST/ALT less then two times normal 7. ECOG performance status of 0, 1 or 2. 8. Patients of both genders must be willing to practice effective birth control during this trial. 9. Patient agreed to participate in the study and has signed a written informed consent, 10. The patient must be eligible to receive IL-2. Exclusion Criteria: Patients will be excluded: 1. who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer. 2. have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. 3. who require steroid therapy. 4. who are pregnant (because of possible side effects on the fetus). 5. who are known to be positive for hepatitis BsAG, HCV, or HIV antibody (because of possible immune effects of these conditions). 6. who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) 7. who are allergic to eggs. i. who have an active major medical illnesses such as cardiac ischemia as evidenced by a stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease (to be eligible to receive IL-2 ) j. Have an abnormal thyroid function (to be eligible to receive IL-2). Trial Lead Organizations/Sponsors Hadassah University Hospital
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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