Know Cancer

or
forgot password

High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study


Phase 2
18 Months
N/A
Open (Enrolling)
Both
Neuroblastoma

Thank you

Trial Information

High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study


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.

- High-risk NB as defined by risk-related treatment guidelines1 and the International
NB Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of
age) MYCN amplification or MYCN-amplified stage 4S.

- Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined
above) resistant to standard therapy, as evidenced by incomplete response in BM, but
no measurable MIBG-avid soft tissue tumor assessable for response and no progressive
disease.

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

Exclusion Criteria:

- Creatinine > 3.0 mg/dL

- ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal

- Bilirubin > 3.0 mg/dL

- Patients with grade 3 or higher toxicities (using the CTCAE v 4.0) related to
cardiac, neurological, pulmonary or gastrointestinal function as determined by
physical exam. Patients must have normal blood pressure for age.

- Progressive disease

- History of allergy to mouse proteins.

- Active life-threatening infection.

- Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

- Inability to comply with protocol requirements.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the activity of high-dose 3F8/GM-CSF

Outcome Description:

against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.

Outcome Time Frame:

2 years

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:

09-161

NCT ID:

NCT01183897

Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Neuroblastoma
  • GM-CSF
  • MAB 3F8
  • RETINOIC ACID (CIS-9 & 13)
  • 09-161
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021