Clinical trial · Interventional
Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
- 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etoposide | Drug | Etoposide | ALIAS |
| isotretinoin | Drug | — | UNRESOLVED |
| monoclonal antibody 3F8 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * High-risk neuroblastoma by: * Histopathology OR * Bone marrow involvement plus elevated urinary catecholamines * Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following: * N-myc amplification in tumor cells * Diploid chromosomal content plus lp loss of heterozygosity in tumor cells * Distant skeletal metastases * Unresectable primary tumor infiltrating across the midline * More than 10% tumor cells in bone marrow * Less than 30% chance of long-term progression-free survival * Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy * No rapidly progressive disease as defined by 1 or more of the following: * Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor * An opiate requirement for pain from tumor * Greater than 25% increase in tumor by successive imaging studies * Life expectancy less than 8 weeks * Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival * No prior myelodysplastic syndromes or leukemia PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * See Disease Characteristics * At least 8 weeks Hematopoietic: * Not specified Hepatic: * No grade 3 or worse liver toxicity Renal: * No grade 3 or worse renal toxicity * Creatinine clearance at least 60 mL/min Cardiovascular: * No grade 3 or worse cardiac toxicity Pulmonary: * No grade 3 or worse pulmonary toxicity Other: * Not pregnant * No grade 3 or worse gastrointestinal toxicity * No grade 3 or worse neurologic system toxicity * No grade 4 hearing deficit * No active life-threatening infection * No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL * No allergy to mouse proteins PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available