Gastric Cancer Clinical Trial
Official title:
An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemotherapy For Advanced Disease (Stage IV)
Verified date | July 2012 |
Source | Jonsson Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs
used in chemotherapy use different ways to stop tumor cells from dividing so they stop
growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and
chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or
esophageal cancer.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 2002 |
Est. primary completion date | January 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent. - Gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction, histologically proven. - Measureable metastatic disease. - Male or female subjects, age 18 years and older. - Karnofsky performance status score equal to or greater than 70. - Life expectancy of at least 3 months. - Subjects must be chemotherapy naïve. - At least 6 weeks from prior curative radiotherapy and 3 weeks from surgery. - Adequate hematological and coagulation parameters: hemoglobin>9.5 g/dL; white blood cell count>3x10^9/L, platelets> 100x10^9/L; international normalized ratio of prothrombin time <1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits. - Adequate clinical chemistry parameters: creatinine<1.5mg/dL; total bilirubin<1.5mg/dL; and aspartate aminotransferase and alanine aminotransferase <2.5x upper normal levels. - Able to comply with scheduled follow-up and with management of toxicity. - Use contraceptive measures, if sexually active Exclusion Criteria: - Previous or current malignancies other than gastric adenocarcinoma, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or nonmelanoma skin cancer - Female subjects who are pregnant or nursing - Female subjects with reproductive potential refusing a pregnancy test - Any previous palliative chemotherapy, adjuvant or neoadjuvant chemotherapy, or investigational drug - Any prior anticancer immunotherapy - Immunodeficiency - Bone marrow transplantation within 1 year - Symptomatic peripheral neuropathy > Grade 2 NCI-CTC, Version 2.0 criteria - Severe hearing disorder > Grade 2 NCI-CTC, Version 2.0 criteria - Known dihydropyrimidine dehydrogenase deficiency - Any other sever condition as defined by the following: unstable cardiac disease despite treatment; myocardial infarction within 6 months before study entry; history of significant neurologic or psychiatric disorders including dementia or seizures; active uncontrolled infection; active disseminated intravascular coagulation; or any other serious underlying medical conditions that could impair the ability of the subject to participate in the study - Subjects who have previously demonstrated hypersensitivity to diphtheria toxoid - Subjects who require chronic administration of corticosteroids - Use in the past 30 days or concomitant use of immunosuppressants - Use in the past 14 days or chronic concomitant use of proton pump inhibitors - Subjects who have a history of hypercalcemia - Subjects who cannot be regularly followed up for psychological, social, familial, or geographic reasons - Subjects with expected noncompliance to toxicity management |
Country | Name | City | State |
---|---|---|---|
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center |
United States,
Ajani JA, Hecht JR, Ho L, Baker J, Oortgiesen M, Eduljee A, Michaeli D. An open-label, multinational, multicenter study of G17DT vaccination combined with cisplatin and 5-fluorouracil in patients with untreated, advanced gastric or gastroesophageal cancer — View Citation
Hecht JR, Ajani JA, Michaeli D: A multicenter phase II study of cisplatin (CDDP) and 5-fluorouracil (5-FU) in combination with G17DT immunogen in patients with locally recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction prev
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer. | 6 months to 1 year | ||
Secondary | Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population. | 6 months to 1 year |
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