Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
trastuzumab
+ conventional surgery
Néoplasmes+4
+ Néoplasmes par type histologique
+ Néoplasmes du tissu conjonctif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin). Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate. Patients are followed for 1 year for survival. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.
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.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 recurrent osteosarcoma after initial systemic therapy with doxorubicin Measurable disease Immunohistochemical evidence of 2+ overexpression of HER2 PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: ALT or AST less than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: Fractional shortening at least 29% by echocardiogram OR Ejection fraction at least 50% by MUGA No prior cardiac dysfunction, even if presently controlled Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior anthracycline more than 450 mg/m^2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent cancer therapy
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 4 sites
City of Hope Comprehensive Cancer Center
Duarte, United StatesOuvrir City of Hope Comprehensive Cancer Center dans Google MapsDana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, United StatesMemorial Sloan-Kettering Cancer Center
New York, United StatesSt. Jude Children's Research Hospital
Memphis, United States