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

Stomach Neoplasms Clinical Trial

Official title:

Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042510
• Other study ID #: GC4
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2002
• Last updated: August 27, 2014
• Start date: August 2000
• Est. completion date: July 2004

Study information

• Verified date: August 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2004
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Biological:
• Treatment group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means.		Through Week 29	Yes
Secondary	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.		Through Week 29	Yes