Metastatic Disease Clinical Trial
Official title:
Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
Verified date | December 2012 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Israel Ministry of Health |
Study type | Interventional |
This study is based on the hypothesis that stimulation of the immune response against the
tumor can help destroy residual tumor in melanoma patients with very high risk for disease
recurrence and in patients with relatively low tumor burden who already got first line
treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients
with a cell line of tumor cells from the patient himself, or with a combination of three
cell lines that partially match the patient's cell characteristics, could improve the immune
response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell
vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine
consists of a cell line that has a high expression level of melanoma molecules, and has been
genetically modified to induce a strong immune response.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible. 2. Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm). 3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes. 4. Metastatic melanoma AJCC stage IV, completely resected. 5. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma. 6. Melanoma can be of either mutant or wild-type B-RAF. 7. Karnofsky performance status over 80 (Normal activity with effort). 8. No active cardio-respiratory disease. 9. Hematocrit over 25% and WBC over 3000. 10. Informed consent of the patient. Exclusion Criteria: 1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration. 2. Active brain metastases requiring cortico-steroids. 3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer). 4. Active serious infection. 5. Allergy to penicillin. 6. Patient's wish to withdraw from the study at any stage. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Emergence of anti-tumor T cell reactivity | To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start | No | |
Primary | Number of adverse effects | For 20 weeks from the start of treatment | Yes | |
Secondary | Overall and disease free survival | For at least five years | No |
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