Clinical Trial Details
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NCT01419834 : Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors
PhasePhase 1
AgesMin: 2 Years Max: N/A
Inclusion Criteria:

- 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 tumor that is
GD2-positive by immunostaining with m3F8.

°A non-NB tumor is defined as GD2-positive by immunostaining with m3F8. If fresh or
frozen tumor is not available for immunostaining, patients will be considered eligible
if published reports show that >50% of that tumor type is GD2-positive by
immunohistochemistry. (Note: Tissues must be fresh/frozen as fixed, paraffin-embedded
specimens are unsuitable for anti-GD2 immunostaining). Tumors known to be GD2-positive
by this criteria do not need immunostaining. These include: Melanoma (>50%),
Desmoplastic small round cell tumors (70%), Osteosarcoma (88%) and Soft tissue
sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma,
leiomyosarcoma, and spindle cell sarcoma (93%).

- 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
GD2-positive tumor.

- 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

Exclusion Criteria:

- 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 ? to 25,000/ul

- Active life-threatening infection.

- Pregnant women or women who are breast-feeding.

- Inability to comply with protocol requirements.
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