Phase I Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma
- Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
- Patients must have either refractory or relapsed high-risk NB (including
MYCNamplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients
greater than 18 months of age) resistant to standard therapy*.
*For NB, standard therapy includes intensive induction chemotherapy, followed by a
variety of consolidation or salvage therapies, depending on response.
- Patients must be older than 1 year of age.
- Prior treatment with murine and humanized 3F8 is allowed. Patients with prior m3F8,
hu3F8, ch14.18 or hu14.18 treatment must have HAHA antibody titer ≤1300 Elisa
units/ml. Human anti-mouse antibody positivity is allowed.
- White blood cell count ≥1000/ul
- Absolute neutrophil count ≥500/ul
- Absolute lymphocyte count ≥500/ul
- Platelet count ≥25,000/ul
- No chemotherapy or immunotherapy for a minimum of three weeks prior to study
- Women of child-bearing potential must be willing to practice an effective method of
birth control while on treatment
- Signed informed consent indicating awareness of the investigational nature of this
- Existing major organ dysfunction > grade 2, with the exception of hearing loss and
hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and
- Active life-threatening infection.
- Pregnant women or women who are breast-feeding.
- Inability to comply with protocol requirements, including PK studies and genetic
- History of allergy to mouse proteins.
- Human anti-hu3F8 antibody (HAHA) titer >1300 Elisa units/ml.
- History of allergy to GM-CSF