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Report for Clinical Trial NCT00020787

Developed by Shray Alag, 2020.
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
Group Labels: 1

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
Group Labels: 1

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
Group Labels: 1

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

Allocation: N/A

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: