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Phase I Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma


Phase 1
1 Year
N/A
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

Phase I Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma


Inclusion Criteria:



- Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
levels.

- Patients must have either refractory or relapsed high-risk NB (including
MYCNamplified 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*.

*For NB, standard therapy includes intensive induction chemotherapy, followed by a
variety of consolidation or salvage therapies, depending on response.

- Patients must be older than 1 year of age.

- Prior treatment with murine and humanized 3F8 is allowed. Patients with prior m3F8,
hu3F8, ch14.18 or hu14.18 treatment must have HAHA antibody titer ≤1300 Elisa
units/ml. Human anti-mouse antibody positivity is allowed.

- 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
enrollment

- 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
program.

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
platelets).

- Active life-threatening infection.

- Pregnant women or women who are breast-feeding.

- Inability to comply with protocol requirements, including PK studies and genetic
studies.

- History of allergy to mouse proteins.

- Human anti-hu3F8 antibody (HAHA) titer >1300 Elisa units/ml.

- History of allergy to GM-CSF

Type of Study:

Interventional

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:

hu3F8 when combined with GM-CSF. DLT is defined after 1 cycle. Nine dosage levels of hu3F8 will be tested with three to six patients at each dosage level.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Brian Kushner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-230

NCT ID:

NCT01757626

Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Neuroblastoma
  • Bone Marrow
  • Hu3F8
  • GM-CSF
  • 12-230
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021