Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors

Fecha de inicio: 1 de marzo de 1997

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