SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01898039

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01898039 Malignant Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: A2/4-1BBL melanoma vaccine

Description: 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.
Type: Biological
Group Labels: 1

A2/4-1BBL melanoma vaccine

Name: DNP sensititzation

Description: 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.
Type: Procedure
Group Labels: 1

A2/4-1BBL melanoma vaccine

Name: Cyclophosphamide

Description: On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.
Type: Drug
Group Labels: 1

A2/4-1BBL melanoma vaccine


Primary Outcomes

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: Day 1

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

Measure: monitoring anti-tumor immune response

Time: Day 0

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: Day 28

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: Day 56

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: month 3

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: month 4

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: month 5

Measure: grade 2-4 adverse events according to CTCEA criteria

Time: month 6

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

Measure: monitoring anti-tumor immune response

Time: Day 28

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

Measure: monitoring anti-tumor immune response

Time: Day 56

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

Measure: monitoring anti-tumor immune response

Time: month 3

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

Measure: monitoring anti-tumor immune response

Time: month 4

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

Measure: monitoring anti-tumor immune response

Time: month 5

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

Measure: monitoring anti-tumor immune response

Time: month 6

Secondary Outcomes

Measure: overall survival and disease free survival

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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---



HPO Nodes


HPO: