A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
dendritic cell vaccine therapy
+ conventional surgery
Maladies génito-urinaires+13
+ Adénocarcinome
+ Carcinome
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this regimen in this patient population. III. Evaluate the clinical response to this regimen in this patient population. OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation. Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation. Patients are assigned to 1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients receive vaccinations as in arm I, except DC are pulsed with tumor cells. Arm III: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients receive vaccinations as in arm III, except DC are treated as in arm II. Patients are followed on days 28, 42, 70, and 112. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.14 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm Over 18 ECOG 0-1 Hematopoietic: Hemoglobin at least 10 g/dL (not transfusion dependent) Platelet count at least 75,000/mm3 WBC greater than 3,000/mm3 Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN PT/PTT no greater than 1.5 times ULN Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.0 g/dL Hepatitis B surface antigen negative Negative pregnancy test Fertile patients must use effective contraception At least 4 weeks since prior immunotherapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy At least 14 days since prior acute therapy for infection Exclusion Criteria: uncontrolled CNS metastasis ischemic heart disease that precludes surgery pulmonary condition that precludes surgery other underlying condition or allergy that would preclude study acute viral, bacterial, or fungal infection requiring therapy HIV negative pregnant or nursing other acute medical problems that would preclude study concurrent corticosteroids (oral, topical, inhaled) prior organ allografts
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesOuvrir Jonsson Comprehensive Cancer Center, UCLA dans Google Maps