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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2002 by Aphton. Recruitment status was Active, not recruiting

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

Sponsor:	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

U.S. FDA Resources

Further study details as provided by Aphton:

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

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

Keywords provided by Aphton:

Gastroesophageal cancer
Gastric cancer

Additional relevant MeSH terms:

Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Stomach Diseases

ClinicalTrials.gov processed this record on February 09, 2012