Clinical trial · Interventional
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR 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. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced 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 |
|---|---|---|---|
| monoclonal antibody 3F8 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Neuroblastoma diagnosed by INSS criteria, i.e., either: * Histologic proof of disease OR * Tumor clumps in bone marrow plus elevated catecholamine levels * Relapsed disease with poor long-term prognosis as indicated by at least one of the following: * N-myc amplification in tumor cells * Diploid chromosomal content in tumor cells * Distant skeletal metastases * Unresectable primary tumor crossing the midline * Bone marrow with greater than 10% tumor cells * Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required * No rapidly progressive disease * Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols PATIENT CHARACTERISTICS: Age: * 2 to 21 Performance status: * Not specified Life expectancy: * Greater than 8 weeks Hematologic: * Not specified Hepatic: * No grade 3/4 toxicity * LDH no greater than 1.5 times upper limit of normal Renal: * Creatinine clearance at least 60 mL/min * No grade 3/4 toxicity Cardiovascular: * No grade 3/4 toxicity Pulmonary: * No grade 3/4 toxicity Other: * No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit * No active life threatening infections * No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL * No allergy to mouse proteins * No pain requiring opiates PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
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