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3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Brian Kushner, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center


The purpose of this study is to see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.

Clinical Details

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

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

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

Secondary outcome:

Apply real-time quantitative RT-PCR

Monitor safety of the high-dose antibody treatment


Minimum age: 18 Months. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: August 2010
Last updated: October 15, 2014

Page last updated: August 23, 2015

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