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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
Sponsor:
Information provided by:
Aphton
ClinicalTrials.gov Identifier:
NCT00042510
First received: July 31, 2002
Last updated: June 23, 2005
Last verified: July 2002
History of Changes
  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 2

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:

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
Gastrins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013