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Phase 2 N=291 Treatment

Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma

Neuroblastoma

Bottom Line

View on ClinicalTrials.gov: NCT00072358 ↗
Enrolled (actual)
291
Serious AEs
52.6%
Results posted
May 2022
Primary outcome: Primary: Efficacy at Completion of Treatment

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
anti-GD2 murine IgG3 monoclonal antibody 3F8 (Biological)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Efficacy at Completion of Treatment		 — —
PRIMARY
Relapse-free Survival Every 3 Months		 — —
SECONDARY
Compare Granulocyte Activation in Patients Treated With Short-term vs Prolonged Daily Exposure to Sargramostim (GM-CSF) After 4 Courses		 — —
SECONDARY
Simplify Treatment With Consequent Reduction in Cost		 — —

Summary

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. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels
  • Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages:
  • Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification
  • MYCN-amplified other than stage 1
  • No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow)
  • No progressive disease or MIBG-avid soft tissue tumor

PATIENT CHARACTERISTICS:

  • No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3
  • No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL
  • No history of allergy to mouse proteins
  • No active life-threatening infection
  • Not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • Not specified
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00072358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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