SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01659151

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Clinical Trial of Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma

The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells). A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system.

NCT01659151 Metastatic Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

4 Interventions

Name: High Dose Interleukin-2 (IL-2)

Description: A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.

Type: Drug

Combination Therapy

Name: ACT with TIL Infusion

Description: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).

Type: Procedure

Combination Therapy

Name: Vemurafenib

Description: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.

Type: Drug

Combination Therapy

Name: Lymphodepletion

Description: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.

Type: Drug

Combination Therapy


Primary Outcomes

Description: Overall response (OR) is defined as the patient being alive at week 6, confirmed at week 12 and tumor size evaluated at both times using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 6 weeks after the cell infusion, then confirmed by CT scanning approximately 12 weeks after the cell infusion, and by clinical evaluation during the first 12 weeks. The complete response rate, complete and partial response rate (CPR) will be summarized using both a point estimate and its 95% exact confidence interval based on the binomial distribution.

Measure: Overall Response (OR)

Time: 12 months

Description: The drop-out rate will be summarized using both a point estimate and its 95% exact confidence interval based on the binomial distribution. For the secondary endpoint, drop-out rate, the power will be 0.66 and 0.91 at the end of stage 1 and 2, respectively, for detecting a desired drop-out rate of ≤ 20% against an expected baseline drop-out rate of ≥ 40% (based on our experience, that of the National Cancer Institute, and that seen at MD Anderson Cancer Center) using a one-sided binomial test at alpha error of 0.05.

Measure: Drop Out Rate

Time: Up to 12 months

Secondary Outcomes

Description: Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed and appropriate. This secondary endpoint will be reported descriptively.

Measure: Number of Participants with Progression Free Survival (PFS)

Time: 12 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

- Residual measurable disease after resection of target lesion(s) for TIL growth - Tumor must have a B-RAF V600E, D or K mutation by pyrosequencing, Cobas assay, or equivalent (43) - Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 - 1. ECOG performance status of 0-1 will be inferred if the patient's level of energy is ≥ 50% of baseline. --- V600E ---



HPO Nodes


HPO:
Cutaneous melanoma
Genes 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R