Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
aldesleukin
+ daclizumab
Maladies de la moelle osseuse+20
+ Maladie chronique
+ Maladies Hématologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma. Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution. Evaluate the immunogenicity of HAT. Identify immunologic parameters that correlate with efficacy. Evaluate the preliminary efficacy of HAT in these patients. Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability). OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia). Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies. Patients are followed weekly for 2 months. PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML 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.25 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
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of one of the following malignancies: Hodgkin's lymphoma Acute myelogenous leukemia Chronic myelogenous leukemia Failed standard therapy or in chronic phase if on standard therapy At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells Measurable disease No symptomatic CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Greater than 2 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times normal No significant hepatic disease Renal: Creatinine no greater than 3 times normal No significant renal disease Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease Other: No significant endocrine, rheumatologic, or allergic disease No HIV-I antibody No active disease due to any of the following: Cytomegalovirus Herpes simplex virus I/II Hepatitis B or C Tuberculosis Negative pregnancy test required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine anti-Tac monoclonal antibody Chemotherapy: At least 4 weeks since chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: Not specified Other: Concurrent treatment allowed for complications of primary disease
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
Beth Israel Deaconess Medical Center
Boston, United StatesOuvrir Beth Israel Deaconess Medical Center dans Google Maps