SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00020787
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
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: