SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01898039

Developed by Shray Alag, 2019.
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

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

A2/4-1BBL melanoma vaccine

Name: Cyclophosphamide

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

Type: Drug

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

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:
Cutaneous melanoma
Genes 11
BRAF HRAS XPC CDKN2A POLH ERCC3 BAP1 CXCR4 MC1R NRAS WRN
Melanoma
Genes 64
RAD51 RAD51C TYR RAD51D CDKN2A KRAS CDKN2B RAF1 CDKN2D MRE11 CYSLTR2 ERCC2 KLLN PTPN11 ERCC3 BRIP1 ERCC4 ERCC5 ERCC6 SF3B1 NRAS MGMT BRCA1 MBTPS2 BRAF ACD BRCA2 PIK3CA CXCR4 CTSC POLH POT1 MC1R MITF WRN CHEK2 HRAS BARD1 NBN AKT1 SLC45A2 GNA11 TRPV3 XPA OCA2 XPC GNAQ PTEN MDM2 TERT DDB2 RNF43 PALLD PALB2 TERF2IP SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 RAD50