A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma
keyhole limpet hemocyanin
+ sargramostim
+ tumor cell-based vaccine therapy
Maladies hématologiques et lymphatiques+11
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 25 juin 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a specific immune response against the B cell idiotype of the malignant clone that constitutes the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II. Determine the safety and toxicity of this treatment regimen using Genitope Corporation's molecular rescue technology in this patient population. OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone, vincristine, and prednisone (CNOP). Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 6 courses. At 2-6 months following completion of chemotherapy, patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ) followed by sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until disease progression. PROJECTED ACCRUAL: Not specified
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.De 18 à 120 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 aggressive non-Hodgkin's lymphoma Diffuse mixed cell Diffuse large cell Immunoblastic Follicular large cell with more than 50% large cells Mantle cell Non-age adjusted International Prognostic Index 2-4 Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy Must have adequate circulating lymphoma cells Over 18 years old Karnofsky 80-100% WBC greater than 2,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 10 g/dL Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal Creatinine less than 2.0 mg/dL Fertile patients must use effective contraception during and for 6 months after the study At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent HIV negative Exclusion Criteria: No CNS metastasis No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing/negative pregnancy test No prior biologic therapy for lymphoma No prior cytotoxic chemotherapy for lymphoma No prior steroids for lymphoma No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent No prior radiotherapy for lymphoma
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 2 sites
Stanford University Medical Center
Stanford, United StatesOuvrir Stanford University Medical Center dans Google MapsUniversity of Nebraska Medical Center
Omaha, United States