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Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors

Phase 1
13 Months
Open (Enrolling)

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Trial Information

Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors

Inclusion Criteria:

- Patients must have either (1) a diagnosis of NB as defined by international
criteria,84 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

o 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 2/3/4/4S of any age 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 after receiving available life-prolonging therapies.

*For NB, standard therapy generally includes 5-8 cycles of high dose induction
chemotherapy followed by resection of gross residual tumor, with or without
myeloablative chemotherapy with peripheral blood stem cell rescue and radiation
therapy to the primary site. There are also salvage chemotherapy regimens for
residual disease after standard induction therapy or for relapsed NB. Some examples
of these chemotherapy combinations are: high-dose cyclophosphamide, topotecan and
vincristine; high-dose cyclophosphamide, irinotecan and vincristine; irinotecan and
temozolomide; or ifosfamide, carboplatin and etoposide.

- Patients must be older than 1 year of age.

- Prior treatment with murine 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18
or hu14.18 treatment must have HAHA antibody titer less than or = to 1300 Elisa

- 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

Exclusion Criteria:

- 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

- Hematologic and primary CNS malignancies

- 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:

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

Outcome Measure:

maximum tolerated dosage

Outcome Description:

of hu3F8 when combined with rIL-2. Five dosage levels of hu3F8 will be tested with three to six patients at each dosage level.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Stephen Roberts, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Neuroblastoma
  • MAB 3F8
  • GD2-positive tumor
  • 12-116
  • Neuroblastoma



Memorial Sloan Kettering Cancer Center New York, New York  10021