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
Summary
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-PCRMonitor safety of the high-dose antibody treatment
Eligibility
Minimum age: 18 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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