SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00020787

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemotherapy For Advanced Disease (Stage IV)

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or esophageal cancer.

NCT00020787 Esophageal Cancer Gastric Cancer
MeSH: Stomach Neoplasms Esophageal Neoplasms
HPO: Esophageal neoplasm Neoplasm of the stomach

3 Interventions

Name: G17DT Immunogen

Description: Dose: 500 micrograms in 0.2mL Route: Deep intramuscular Schedule: Days 8, 36, and 64; an additional dose at week 2, cycle 7 will be administered

Type: Biological

Treatment

Name: cisplatin

Description: dose: 100 mg/m2 Route: i.v. infusion in 500 mL in 0.9% NaCl administered up to 3 hours Schedule: day 1, and then every 4 weeks.

Type: Drug

Treatment

Name: fluorouracil

Description: Dose: 1000mg/m2/day Route: 24-hour continuous infusion in 0.9% NaCl over 5 days Schedule: Day 1 to Day 5 (5-day infusion) and then every 4 weeks

Type: Drug

Treatment


Primary Outcomes

Measure: To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer.

Time: 6 months to 1 year

Secondary Outcomes

Measure: Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population.

Time: 6 months to 1 year

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 G17T

An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemotherapy For Advanced Disease (Stage IV). --- G17T ---



HPO Nodes


HPO:
Esophageal neoplasm
Genes 18
ASCC1 MSR1 RNF6 RHBDF2 APC PDGFRA CTHRC1 KIT TGFBR2 STK11 DLEC1 STAT1 SDHA SDHB SDHC WWOX RAD21 FH
Neoplasm of the stomach
Genes 59
CDKN2A KRAS CDKN2B CDKN2D STK11 MSH6 TREX1 ERBB2 BMPR1A DLC1 NRAS MGMT ACD KLF6 PDGFRA PIK3CA POT1 SRC BUB1 BUB1B MC1R MITF CHEK2 PTCH2 APC MLH1 PRKAR1A FLCN CASP10 IRF1 AKT1 RPS20 BCL10 MSH2 FGFR3 MSH3 FGFR2 SEMA4A CTNNB1 DCC PTCH1 BUB3 SUFU CEP57 ENG CDH1 TRIP13 KIT TERT EP300 TERF2IP MUTYH SDHA SDHB SDHC AXIN2 SMAD4 BAP1 CDK4