Clinical trial · Interventional
Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic 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: Biological therapies such as beta-glucan use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta-glucan | Biological | — | UNRESOLVED |
| monoclonal antibody 3F8 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 49 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed high-risk stage 4 metastatic neuroblastoma * May be confirmed by bone marrow involvement and elevated urinary catecholamines * Progressive or persistent disease after intensive conventional chemotherapy that included induction with N6, N7, N8, or COG protocol with or without bone marrow or stem cell transplantation * Poor long-term prognosis as defined by any of the following: * N-myc amplification in tumor cells * Diploid chromosomal content plus 1p loss of heterozygosity in tumor cells * Distant skeletal metastases * Unresectable primary tumor infiltrating across the midline * More than 10% tumor cells in bone marrow * Measurable or evaluable disease documented at least 4 weeks after completion of prior systemic therapy PATIENT CHARACTERISTICS: Age: * Under 50 Performance status: * Not specified Life expectancy: * See Disease Characteristics Hematopoietic: * Platelet count greater than 25,000/mm\^3 * Absolute neutrophil count greater than 500/mm\^3 Hepatic: * Not specified Renal: * Creatinine clearance greater than 60 mL/min Other: * No severe major organ toxicity * No active life-threatening infections * No prior allergy to mouse proteins * No prior allergy to beta-glucan, oats, barley, mushrooms, or yeast * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or as complementary medicine
References
Publications (0)
Data not yet available