Clinical trial NCT01861938: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: 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
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse effects
timeFrame: For 20 weeks from the start of treatment
Secondary outcomes:
measure: Overall and disease free survival
timeFrame: For at least five years
Other outcomes:
measure: Emergence of anti-tumor T cell reactivity
timeFrame: To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start
Locations:
Study officials:
References: