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3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma: A Phase I Trial

Phase 1
21 Years
Open (Enrolling)

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Trial Information

3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma: A Phase I Trial


- Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with
sargramostim (GM-CSF) in young patients with high-risk, refractory or relapsed

- Assess anti-neuroblastoma effects of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of monoclonal antibody 3F8.

Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11 and
monoclonal antibody 3F8 IV over 30 minutes on days 0-4 and 7-11. Treatment repeats every 4-6
weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody 3F8 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years.

Inclusion Criteria:

- Patients must have a diagnosis of NB as defined by international criteria,45 i.e.,
histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus
high urine catecholamine levels.

- Patients must have refractory or relapsed high-risk NB (including MYCNamplified stage
3/4/4S and MYCN-nonamplified stage 4 >18 months old) resistant to standard therapy.

- Prior treatment with 3F8 is allowed.

- Age <21 years.

- Signed informed consent indicating awareness of the investigational nature of this

Exclusion Criteria:

- Existing major organ dysfunction should be grade 2 or less, with the exception of
myelosuppression (neutrophil count >500/ul and platelet count >10,000/ul are
acceptable), alopecia, hearing loss. Patient cannot be taking antihypertensive

- History of allergy to mouse proteins.

- Active life-threatening infection.

- Human anti-mouse antibody (HAMA) titer >1000 ELISA units/ml.

- Prior treatment with 3F8 is NOT an exclusion criterion.

- Inability to comply with protocol requirements.

- Pregnant women are excluded for fear of danger to the fetus. Therefore negative
pregnancy test is required for all women of child-bearing age, and appropriate
contraception is used during the study period.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of monoclonal antibody 3F8

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Brian H. Kushner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

December 2013

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • stage 4S neuroblastoma
  • disseminated neuroblastoma
  • localized unresectable neuroblastoma
  • regional neuroblastoma
  • Neuroblastoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021