Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors
BCG vaccine
+ monoclonal antibody A1G4 anti-idiotype vaccine
Néoplasmes+12
+ Néoplasmes par type histologique
+ Néoplasmes du tissu conjonctif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 1997
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin (BCG) adjuvant. Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients. OUTLINE: All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin (BCG) organisms. The vaccine is injected intradermally in multiple sites. Booster immunizations are administered during weeks 2, 4, 8, 12, 20, 28, 36, 44, 52. Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated. Isoniazid is administered for 5 days after each BCG injection. If severe skin reactions are present at the injection site, the BCG dose is decreased. If skin reactions persist, the BCG dose is stopped but A1G4 injections continue. At least 6 patients are accrued at each dose level of A1G4. Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity. If 0-1 patient experiences dose limiting toxicity (DLT) at a given dose level, then patients are accrued to the next higher dose level. If 2 or more patients experience DLT, the MTD is defined as the previous dose level. Patients are followed for at least 1 year. PROJECTED ACCRUAL: A total of 24 patients are expected to complete this study. If patients are removed early from the study prior to evaluation for serological response, additional patients will be accrued until 6 patients are evaluable for serological response.
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.24 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: Histologically confirmed GD2 positive tumors which include: High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent) Recurrent or metastatic osteosarcoma Recurrent or metastatic GD2 positive sarcomas If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery) No greater than 6 months since last chemotherapy or surgery before first injection of A1G4 PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than 500/mm^3 Absolute leukocyte count greater than 500/mm^3 Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal Hepatic: Not specified Renal: Not specified Cardiovascular: No significant heart disease (NYHA class III or IV) Other: No other serious intercurrent illnesses No active infections requiring antibiotics No active bleeding No primary immunodeficiency Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antibiotics No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer Chemotherapy: See Disease Characteristics At least 6 weeks since nitrosoureas At least 4 weeks since other systemic chemotherapy Endocrine therapy: No concurrent nonsteroidal anti-inflammatory agents No concurrent corticosteroid Radiotherapy: At least 4 weeks since radiotherapy No prior radiation therapy to the spleen Surgery: See Disease Characteristics No splenectomy
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