Clinical trial · Interventional
Vaccine Therapy Plus Chemotherapy in Treating Patients With Metastatic or Locally Recurrent Stomach Cancer or Esophageal Cancer
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)
NCT00020787CI-TRIAL-00046378completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| G17DT Immunogen | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- See intervention description.
- interventionNames
- Biological: G17DT Immunogen
- Drug: cisplatin
- Drug: fluorouracil
Primary outcomes (1)
- measure
- To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer.
- timeFrame
- 6 months to 1 year
Secondary outcomes (1)
- measure
- Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population.
- timeFrame
- 6 months to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAjani 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: the GC4 study. Cancer. 2006 May 1;106(9):1908-16. doi: 10.1002/cncr.21814. PMID 16568451
- RESULTHecht 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 previously untreated for advanced disease. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1035, 258, 2003.