Safety and Efficacy of G17DT Immunogen in the Treatment of Advanced Pancreatic Carcinoma

This study is ongoing, but not recruiting participants.

Sponsored by:	Aphton
Information provided by:	Aphton
ClinicalTrials.gov Identifier:	NCT00044031

Purpose

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

Condition	Intervention	Phase
Pancreatic Cancer	Drug: G17DT Immunogen	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Aphton:

Study Start Date:

February 2001

Eligibility

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

Criteria

Inclusion criteria:

Clinical diagnosis of pancreatic adenocarcinoma
Life expectancy of at least 3 months
Functional status by Karnofsky Index of at least 70

Exclusion criteria:

Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
Immunodeficiency
Bone marrow transplant within past year
Brain metastasis

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	PC4
Study First Received:	August 16, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00044031
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009