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NCT Number: NCT01898039

Modified Vaccine for High Risk or Low Residual Melanoma Patients

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sharett Institute of Oncology, Hadassah Medical Organization

Jerusalem, 91120, Israel

Location status: Recruiting

Location contact

Hani Steinberg, RN

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (>4 mm) or IIc (ulcerated melanoma >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-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.
  • 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 > 80 (Normal activity with effort).
  • No active cardio-respiratory disease.
  • Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >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 corticosteroids.
  • Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
  • Active serious infection.
  • Allergy to penicillin.
  • Patient's will to withdraw from the study at any stage.
  • HIV and chronic hepatitis B and C carrier

Treatment and study plan

A2/4-1BBL melanoma vaccine

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.

Other names: M20/A2B vaccine

DNP sensititzation

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

Drug

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

Primary outcomes

  1. grade 2-4 adverse events according to CTCEA criteria

    Time frame: Day 1

  2. monitoring anti-tumor immune response

    Time frame: Day 0

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response.

  3. grade 2-4 adverse events according to CTCEA criteria

    Time frame: Day 28

  4. grade 2-4 adverse events according to CTCEA criteria

    Time frame: Day 56

  5. grade 2-4 adverse events according to CTCEA criteria

    Time frame: month 3

  6. grade 2-4 adverse events according to CTCEA criteria

    Time frame: month 4

  7. grade 2-4 adverse events according to CTCEA criteria

    Time frame: month 5

  8. grade 2-4 adverse events according to CTCEA criteria

    Time frame: month 6

  9. monitoring anti-tumor immune response

    Time frame: Day 28

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

  10. monitoring anti-tumor immune response

    Time frame: Day 56

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

  11. monitoring anti-tumor immune response

    Time frame: month 3

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

  12. monitoring anti-tumor immune response

    Time frame: month 4

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

  13. monitoring anti-tumor immune response

    Time frame: month 5

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

  14. monitoring anti-tumor immune response

    Time frame: month 6

    Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response

Secondary outcomes

  1. overall survival and disease free survival

    Time frame: D1, Mo6, Mo10, Mo14, Mo18, Mo20, Mo24 and every 4 months till year 5

Study contacts

Contact information is provided by the study sponsor or research team.

Hani Steinberg, RN

CONTACT

[email protected]

972507874292

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2013
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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