Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors
- Patients must have either (1) a diagnosis of NB as defined by international
criteria,56 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or
BM metastases plus high urine catecholamine levels, or (2) a metastatic tumor that is
GD2-positive by immunostaining with m3F8.
- Patients must have either (1) refractory or relapsed high-risk NB (including
MYCN-amplified stage 3/4/4S and MYCN-nonamplified stage 4 in patients greater than 18
months of age) resistant to standard therapy, or (2) refractory or relapsed
- Patients must be older than 1 year of age.
- Prior treatment with murine 3F8 is allowed. Patients with prior m3F8 or ch14.18
treatment must have HAHA antibody titer less than the upper limit of normal [defined
as mean + 3*SD of normal volunteers].
- Negative serum pregnancy test in women of childbearing potential.
- 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
myelosuppression defined as suppression of all types of WBCs, RBCs and platelets).
However, the following parameters must be met: white blood cell count ≥1000/ul,
absolute (neutrophil count >500/ul absolute lymphocyte count ≥500/ul and platelet
count > or = to 25,000/ul
- Patient taking antihypertensive medication.
- Active life-threatening infection.
- Pregnant women or women who are breast-feeding.
- Inability to comply with protocol requirements.