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

NCT ID: NCT00042510

Last Updated: 2014-08-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-07-31

Brief Summary

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

Detailed Description

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Conditions

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Stomach Neoplasms Esophageal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Treatment group

Intervention Type BIOLOGICAL

Interventions

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Treatment group

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Advances Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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