Back to resultsModified Melanoma Vaccine for High Risk or Low Residual Disease Patients
Primary Purpose
High Risk HLA-A2+ Melanoma, Metastatic Disease
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Melanoma vaccine modified to express HLA A2/4-1BB ligand
Sponsored by
About this trial
This is an interventional treatment trial for High Risk HLA-A2+ Melanoma focused on measuring melanoma, vaccine, Resectable AJCC stage IV, AJCC stages IIb-c, III, Patients with low-burden, failed, respond, one treatment line
Eligibility Criteria
Inclusion Criteria:
- 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.
- Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
- Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
- Metastatic melanoma AJCC stage IV, completely resected.
- Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
- Melanoma can be of either mutant or wild-type B-RAF.
- Karnofsky performance status over 80 (Normal activity with effort).
- No active cardio-respiratory disease.
- Hematocrit over 25% and WBC over 3000.
- Informed consent of the patient.
Exclusion Criteria:
- Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- Active brain metastases requiring cortico-steroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- Active serious infection.
- Allergy to penicillin.
- Patient's wish to withdraw from the study at any stage.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Melanoma vaccine
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse effects
Secondary Outcome Measures
Overall and disease free survival
Full Information
NCT ID
NCT01861938
First Posted
December 20, 2012
Last Updated
May 23, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01861938
Brief Title
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
Official Title
Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk HLA-A2+ Melanoma, Metastatic Disease
Keywords
melanoma, vaccine, Resectable AJCC stage IV, AJCC stages IIb-c, III, Patients with low-burden, failed, respond, one treatment line
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melanoma vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Melanoma vaccine modified to express HLA A2/4-1BB ligand
Primary Outcome Measure Information:
Title
Number of adverse effects
Time Frame
For 20 weeks from the start of treatment
Secondary Outcome Measure Information:
Title
Overall and disease free survival
Time Frame
For at least five years
Other Pre-specified Outcome Measures:
Title
Emergence of anti-tumor T cell reactivity
Time Frame
To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
Metastatic melanoma AJCC stage IV, completely resected.
Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
Melanoma can be of either mutant or wild-type B-RAF.
Karnofsky performance status over 80 (Normal activity with effort).
No active cardio-respiratory disease.
Hematocrit over 25% and WBC over 3000.
Informed consent of the patient.
Exclusion Criteria:
Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
Active brain metastases requiring cortico-steroids.
Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
Active serious infection.
Allergy to penicillin.
Patient's wish to withdraw from the study at any stage.
12. IPD Sharing Statement
Learn more about this trial
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
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