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Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Both
High Risk HLA-A2+ Melanoma, Metastatic Disease

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Trial Information

Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of adverse effects

Outcome Time Frame:

For 20 weeks from the start of treatment

Safety Issue:

Yes

Authority:

Israel: Israel Ministry of Health

Study ID:

0419-12-HMO

NCT ID:

NCT01861938

Start Date:

June 2013

Completion Date:

Related Keywords:

  • High Risk HLA-A2+ Melanoma
  • Metastatic Disease
  • melanoma
  • vaccine
  • Resectable AJCC stage IV
  • AJCC stages IIb-c, III
  • Patients with low-burden
  • failed
  • respond
  • one treatment line
  • Melanoma
  • Neoplasm Metastasis

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