HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
monoclonal antibody HeFi-1
Maladies hématologiques et lymphatiques+9
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma. Determine the pharmacokinetics of this drug in this patient population. Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year. Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9 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.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 CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma At least 50% of malignant cells must react with HeFi-1 HIV positive or HIV negative Measurable disease No symptomatic CNS disease Must have failed or be ineligible for standard chemotherapy regimen PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 2 months Hematopoietic: Not specified Hepatic: No significant hepatic disease Bilirubin no greater than 2 mg/dL Renal: No significant renal disease Creatinine no greater than 3 mg/dL Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease Other: No significant endocrine, rheumatologic, or allergic disease No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine antibody therapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to measurable disease Surgery: Not specified Other At least 4 weeks since prior cytotoxic therapy to measurable 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