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

Cancer Advances

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms; Esophageal Neoplasms

Treatments: Biological: Treatment group

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042510

GC4

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

Treatment Group

Experimental group

Description:

500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m\^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m\^2/d.

Treatment:

Biological: Treatment group