Status:
COMPLETED
The Role of Peptide-loaded Dendritic Cells to Augment the Therapeutic Effect of Interleukin-2
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 approa...
Eligibility Criteria
Inclusion
- 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
- Patient must have received accepted standard treatmnet for melanoma - DTIC -containing protocol ,unless unwilling.
- Patients who failed previous treatment with IL-2 will be included on a compassionate basis in the IL-2 plus vaccination scheme without being included in the analysis.
- serum creatinine of 2.0 mg/dl or less,
- 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.
- WBC 3000/mm3 or greater
- platelet count 90,000 mm3 or greater
- serum AST/ALT less then two times normal
- ECOG performance status of 0, 1 or 2.
- Patients of both genders must be willing to practice effective birth control during this trial.
- Patient agreed to participate in the study and has signed a written informed consent,
- The patient must be eligible to receive IL-2.
Exclusion
- Patients will be excluded:
- who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer.
- have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
- who require steroid therapy.
- who are pregnant (because of possible side effects on the fetus).
- who are known to be positive for hepatitis BsAG, HCV, or HIV antibody (because of possible immune effects of these conditions).
- 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.)
- 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).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00279058
Start Date
December 1 2005
End Date
December 1 2008
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91 120