Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer
NCT ID: NCT00042510
Last Updated: 2014-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2000-08-31
2004-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m\^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m\^2/d.
Treatment group
Interventions
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Treatment group
Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status score of at least 70
* Life expectancy of at least 3 months
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cancer Advances Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jaffer A Ajani, M.D.
Role: PRINCIPAL_INVESTIGATOR
U.S. studies
Vladimir Moiseyenko, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Non U.S. studies
Other Identifiers
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GC4
Identifier Type: -
Identifier Source: org_study_id
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