Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer

Cancer Advances Inc.103 enrolled

Overview

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Stomach Neoplasms Esophageal Neoplasms

Interventions

Treatment groupBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Clinical diagnosis with gastric or gastroesophageal cancer * Karnofsky performance status score of at least 70 * Life expectancy of at least 3 months Exclusion criteria: * Prior treatment with chemotherapy or anticancer immunotherapy * Bone marrow transplant within past year * Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease * Central nervous system metastases * Immunodeficiency * Hypercalcemia

Outcomes

Primary Outcomes

To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.

Time frame: Through Week 29

Secondary Outcomes

To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival.

Time frame: Through Week 29

Data from ClinicalTrials.gov

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