En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
Collecte de données
Mélanome+9
+ Néoplasmes germinaux et embryonnaires
+ Néoplasmes par type histologique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma. * Determine the safety and tolerability of this therapy in these patients. Secondary * Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy. OUTLINE: This is a dose-escalation, pilot study. Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56. Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity. Patients are followed at day 84 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.
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.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
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease * Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) * Tumor tissue available and properly stored for lysate preparation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) * Bilirubin ≤ 2 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine ≤ 2.0 times ULN Immunologic * No active infection * No history of autoimmune disease, including any of the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Scleroderma * Rheumatoid arthritis * Multiple sclerosis * No allergy to aminoglycosides or streptomycin * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant comorbid illness * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 10 days since prior immunotherapy Chemotherapy * See Disease Characteristics Endocrine therapy * At least 6 weeks since prior steroid therapy * No concurrent corticosteroids Radiotherapy * At least 10 days since prior radiotherapy * No concurrent radiotherapy Surgery * At least 10 days since prior surgery * Prior diagnostic or palliative surgery allowed provided the patient has fully recovered Other * No concurrent immunosuppressive or potentially immunosuppressive therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
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
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, United StatesOuvrir Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center dans Google Maps