Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

No active cardio-respiratory disease.
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.
Karnofsky performance status > 80 (Normal activity with effort).
...
No active cardio-respiratory disease.
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.
Karnofsky performance status > 80 (Normal activity with effort).
Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
Melanoma can be of either mutant or wild-type B-RAF.
Cutaneous malignant melanoma AJCC stage IIb (>4 mm) or IIc (ulcerated melanoma >4mm).
Informed consent of the patient.
Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >3000.
Metastatic melanoma AJCC stage IV, completely resected.
Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.

Exclusion Criterias

Allergy to penicillin.
HIV and chronic hepatitis B and C carrier
Active serious infection.
...
Allergy to penicillin.
HIV and chronic hepatitis B and C carrier
Active serious infection.
Active brain metastases requiring corticosteroids.
Patient's will to withdraw from the study at any stage.
Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.

Summary

Conditions
Malignant Melanoma
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Inclusion Criterias

No active cardio-respiratory disease.
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.
Karnofsky performance status > 80 (Normal activity with effort).
...
No active cardio-respiratory disease.
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.
Karnofsky performance status > 80 (Normal activity with effort).
Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
Melanoma can be of either mutant or wild-type B-RAF.
Cutaneous malignant melanoma AJCC stage IIb (>4 mm) or IIc (ulcerated melanoma >4mm).
Informed consent of the patient.
Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >3000.
Metastatic melanoma AJCC stage IV, completely resected.
Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.

Exclusion Criterias

Allergy to penicillin.
HIV and chronic hepatitis B and C carrier
Active serious infection.
...
Allergy to penicillin.
HIV and chronic hepatitis B and C carrier
Active serious infection.
Active brain metastases requiring corticosteroids.
Patient's will to withdraw from the study at any stage.
Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.

Locations

Jerusalem, 91120
Jerusalem, 91120

Tracking Information

NCT #
NCT01898039
Collaborators
Not Provided
Investigators
Not Provided