Clinical trial · Interventional
Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin (BCG) Adjuvant in High Risk Patients With GD2 Positive Tumors
NCT00003023CI-TRIAL-00009005completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG vaccine | Biological | — | UNRESOLVED |
| monoclonal antibody A1G4 anti-idiotype vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.