- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00020787
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)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES: I. Determine a safe and immunogenic combination of G17DT with cisplatin and fluorouracil in patients with chemotherapy-naive metastatic or locally recurrent gastric or gastroesophageal cancer. II. Determine the safety profile and tolerability of this regimen in these patients. III. Determine the tumor response rate, disease stabilization, best overall response, time to progression, time to treatment failure, and overall survival in patients treated with this regimen. IV. Determine the correlation of immunological response with clinical efficacy and benefit in patients treated with this regimen. V. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to one of four treatment regimens. Regimen A: Patients receive high-dose G17DT intramuscularly (IM) on days 7, 35, and 63. Patients also receive cisplatin IV over 1-3 hours on day 1 followed by fluorouracil IV continuously over days 1-5 every 4 weeks in the absence of disease progression or unacceptable toxicity. If inadequate immune response is seen on Regimen A, subsequent patients are treated on Regimen B. If unacceptable toxicity is seen on Regimen A, subsequent patients are treated on Regimen C. If inadequate immune response and unacceptable toxicity are seen on Regimen A, or if unacceptable toxicity is seen on Regimen B or inadequate immune response is seen on Regimen C, then subsequent patients are treated on Regimen D. Regimen B: Patients receive high-dose G17DT IM on days 1, 28, and 56. Patients also receive cisplatin IV over 1-3 hours on day 35 followed by fluorouracil IV continuously over days 35-39 every four weeks in the absence of disease progression or unacceptable toxicity. Regimen C: Patients receive low-dose G17DT IM on days 7, 35, and 63 with chemotherapy as in regimen A. Regimen D: Patients receive low-dose G17DT IM on days 1, 28, and 56 with chemotherapy as in regimen B. Quality of life is assessed at baseline, on day 7, every 2 weeks for 10 weeks, and then every 4 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 5-30 months.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Treatment
See intervention description.
|
Dose: 500 micrograms in 0.2mL Route: Deep intramuscular Schedule: Days 8, 36, and 64; an additional dose at week 2, cycle 7 will be administered
dose: 100 mg/m2 Route: i.v.
infusion in 500 mL in 0.9% NaCl administered up to 3 hours Schedule: day 1, and then every 4 weeks.
Autres noms:
Dose: 1000mg/m2/day Route: 24-hour continuous infusion in 0.9% NaCl over 5 days Schedule: Day 1 to Day 5 (5-day infusion) and then every 4 weeks
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer.
Délai: 6 months to 1 year
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6 months to 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population.
Délai: 6 months to 1 year
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6 months to 1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Joel R. Hecht, MD, Jonsson Comprehensive Cancer Center
Publications et liens utiles
Publications générales
- 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: the GC4 study. Cancer. 2006 May 1;106(9):1908-16. doi: 10.1002/cncr.21814.
- 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 previously untreated for advanced disease. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1035, 258, 2003.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs de l'estomac
- Tumeurs de l'oesophage
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Cisplatine
- Fluorouracile
Autres numéros d'identification d'étude
- CDR0000068713
- UCLA-0006040
- APHTON-BB-IND-8737
- NCI-G01-1959
- UCLA-GC4C
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