Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT ID: NCT01898039

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2027-04-30

Brief Summary

This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A2/4-1BBL melanoma vaccine

On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.

On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered at the day care unit. On day 14 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed. Four additional doses of the vaccine will be administered at intervals of 21 days.

Group Type: EXPERIMENTAL

A2/4-1BBL melanoma vaccine

Intervention Type: BIOLOGICAL

On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.

DNP sensititzation

Intervention Type: PROCEDURE

Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site.

On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.

Cyclophosphamide

Intervention Type: DRUG

On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.

Interventions

A2/4-1BBL melanoma vaccine

On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.

Intervention Type: BIOLOGICAL

DNP sensititzation

Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site.

On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.

Intervention Type: PROCEDURE

Cyclophosphamide

On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.

Intervention Type: DRUG

Other Intervention Names

M20/A2B vaccine

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 (>4 mm) or IIc (ulcerated melanoma >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-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.

6. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.

7. Melanoma can be of either mutant or wild-type B-RAF.

8. Karnofsky performance status > 80 (Normal activity with effort).

9. No active cardio-respiratory disease.

10. Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >3000.

11. 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 corticosteroids.

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 will to withdraw from the study at any stage.

7. HIV and chronic hepatitis B and C carrier

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sharett Institute of Oncology, Hadassah Medical Organization

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hani Steinberg, RN

Role: CONTACT

hanis@hadassah.org.il

972507874292

Facility Contacts

Hani Steinberg, RN

Role: primary

hanis@hadassah.org.il

Other Identifiers

0419-12-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id