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Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

Phase 1
Open (Enrolling)
Neuroblastoma, Bone Marrow, Sympathetic Nervous System

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Trial Information

Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

Inclusion Criteria:

- Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed
by the MSKCC Department of Pathology) or bone marrow metastases plus high urine
catecholamine levels

- High-risk NB as defined by risk-related treatment guidelines and the International NB
Staging System,57 i.e., stage 4 with (any age) or without (>365 days of age) MYCN
amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified
stage 4S.

- Patients must have a history of tumor progression or persistent disease or failure to
achieve complete response following standard therapy.

- Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers,
positive MIBG or PET scans) or measurable (CT, MRI) disease documented after
completion of prior systemic therapy.

- Disease staging within one month of treatment.

- Human anti-mouse antibody (HAMA) titer <1000 Elisa units/ml if applicable

- Available autologous stem cells: ≥2 x 106 CD34+ cells/kg

- Adequate cardiac function as measured by echocardiogram

- Eligible NK donor

- Signed informed consent indicating awareness of the investigational nature of this

Donor Eligibility

- Donor is blood-related and HLA-haploidentical to the recipient.

- Donor has undergone serologic testing for transmissible diseases as per blood banking
guidelines for organ and tissue donors. Tests include but are not limited to:
HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, West
Nile Virus and Chagas screen. Donor must have normal negative test results for HIV,
HTLV I and II, and West Nile Virus. Donor exposure to other viral pathogens will be
discussed on a case-by-case basis by the investigators.

- Donor must be able to undergo leukopheresis for total volume of 10-15 liters.

- There is no age restriction for the donor.

Exclusion Criteria:

- Patients with CR/VGPR disease

- Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic,
pulmonary, or gastrointestinal toxicity > or = to grade 3 except for hearing loss,
alopecia, anorexia, nausea, hyperbilirubinemia and hypomagnesemia from TPN, which
may be grade 3

- ANC should be >500/uL; platelet count >25K/uL.

- History of allergy to mouse proteins

- Active life-threatening infection

- HAMA titer >1000 Elisa units/ml

- Inability to comply with protocol requirements

Donor Exclusion Criteria

- Cardiac risk factors precluding ability to undergo leukopheresis

- Concurrent malignancy or autoimmune disease

- Donor is pregnant.

Type of Study:


Study Design:

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

Outcome Measure:

Assess the feasibility and safety of administering allogeneic haploidentical NK infusions with 3F8 in patients with high-risk NB

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Shakeel Modak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

April 2014

Related Keywords:

  • Neuroblastoma
  • Bone Marrow, Sympathetic Nervous System
  • MAB 131 I - 3F8
  • Neuroblastoma
  • 09-011
  • Neuroblastoma



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021