Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
Collecte de données
Néoplasmes germinaux et embryonnaires+7
+ Néoplasmes par type histologique
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma. * Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory \[never had disease progression or disease recurrence\] vs secondary refractory \[recurrent disease that did not respond completely to reinduction therapy\]). * Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11. * Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11. Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) 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.74 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.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: * Diagnosis of neuroblastoma, as defined by 1 of the following: * Histologically confirmed disease * Bone marrow metastases plus high urine catecholamines * High-risk disease meeting 1 of the following stage criteria: * Stage IV, with 1 of the following: * Any age with MYCN amplification * \> 18 months of age without MYCN amplification * Stage III, with both of the following: * Any age with MYCN amplification * Unresectable disease * Stage 4S with MYCN amplification * Measurable or evaluable soft tissue disease * Relapsed disease resistant to standard induction chemotherapy and salvage therapy PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No severe hepatic toxicity ≥ grade 3 Renal * No severe renal toxicity ≥ grade 3 Cardiovascular * No severe cardiac toxicity ≥ grade 3 Pulmonary * No severe pulmonary toxicity ≥ grade 3 Other * Not pregnant * Negative pregnancy test * No severe neurologic toxicity ≥ grade 3 * No severe gastrointestinal toxicity ≥ grade 3 * No other severe major organ dysfunction except ototoxicity * No history of allergy to mouse proteins * No active life-threatening infection * No human anti-mouse antibody titer \> 1,000 ELISA units/mL PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps