Health TrialsbyHealthPanel

Modified Vaccine for High Risk or Low Residual Melanoma Patients

ConditionMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHadassah Medical Organization

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • A2/4-1BBL melanoma vaccine

    Biological/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.

  • DNP sensititzation

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: A2/4-1BBL melanoma vaccineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

grade 2-4 adverse events according to CTCEA criteria

Time frame
Day 1
2

monitoring anti-tumor immune response

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

Time frame
Day 0
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hadassah Medical Organization

Lead sponsor

Source ClinicalTrials.gov
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