Clinical trial · Interventional
Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk 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, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta-glucan | Biological | — | UNRESOLVED |
| isotretinoin | Drug | — | UNRESOLVED |
| monoclonal antibody 3F8 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease response as assessed by PT-PC at the end of 4 courses
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma, as defined by 1 of the following:
* Histologically confirmed disease
* Bone marrow metastases plus high urine catecholamines
* High-risk disease meeting 1 of the following stage criteria:
* Stage IV, with 1 of the following:
* Any age with MYCN amplification
* \> 18 months of age without MYCN amplification
* Stage III, with both of the following:
* Any age with MYCN amplification
* Unresectable disease
* Stage 4S with MYCN amplification
* Measurable or evaluable soft tissue disease
* Relapsed disease resistant to standard induction chemotherapy and salvage therapy
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* No severe hepatic toxicity ≥ grade 3
Renal
* No severe renal toxicity ≥ grade 3
Cardiovascular
* No severe cardiac toxicity ≥ grade 3
Pulmonary
* No severe pulmonary toxicity ≥ grade 3
Other
* Not pregnant
* Negative pregnancy test
* No severe neurologic toxicity ≥ grade 3
* No severe gastrointestinal toxicity ≥ grade 3
* No other severe major organ dysfunction except ototoxicity
* No history of allergy to mouse proteins
* No active life-threatening infection
* No human anti-mouse antibody titer \> 1,000 ELISA units/mL
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available