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

This study is ongoing, but not recruiting participants.

First Received: July 31, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Aphton
Information provided by:	Aphton
ClinicalTrials.gov Identifier:	NCT00042510

Purpose

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

Condition	Intervention	Phase
Stomach Neoplasms Esophageal Neoplasms	Drug: G17DT Immunogen	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	GC4
Study First Received:	July 31, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00042510 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aphton:

Gastroesophageal cancer
Gastric cancer

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Esophageal Disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Cancer
Stomach Cancer
Esophageal Diseases

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases

Head and Neck Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 10, 2009