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Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors

Phase 1
2 Years
Open (Enrolling)

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Trial Information

Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors

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 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
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 > 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dosage (MTD)

Outcome Description:

At least 3 patients will be studied at each dosage level and dose escalations will only be carried out if 0/3 or < or = to 1/6 patients have dose-limiting toxicity (DLT). At least six patients will be studied at the maximum tolerated dosage (MTD).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ellen Basu, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

August 2014

Related Keywords:

  • Neuroblastoma
  • CNS
  • Brain
  • MAB 3F8
  • Hu3F8
  • 11-009
  • Neuroblastoma



Memorial Sloan Kettering Cancer Center New York, New York  10021