Status:
COMPLETED
Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Band of Parents
Y-mAbs Therapeutics
Conditions:
Neuroblastoma
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out if "humanized 3F8" (Hu3F8) is safe for treating neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find out what side effec...
Detailed Description
Patients can be treated on 2 different schedules: For patients following a 2 doses/cycle schedule (patients who were enrolled and started treatment prior to Amendment A(8)), one cycle has 2 days of i...
Eligibility Criteria
Inclusion
- Patients must have either (1) a diagnosis of NB as defined by international criteria,56 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive by immunostaining with m3F8.
- °A non-NB tumor is defined as GD2-positive by immunostaining with m3F8. If fresh or frozen tumor is not available for immunostaining, patients will be considered eligible if published reports show that \>50% of that tumor type is GD2-positive by immunohistochemistry. (Note: Tissues must be fresh/frozen as fixed, paraffin-embedded specimens are unsuitable for anti-GD2 immunostaining). Tumors known to be GD2-positive by this criteria do not need immunostaining. These include: Melanoma (\>50%), Desmoplastic small round cell tumors (70%), Osteosarcoma (88%) and Soft tissue sarcomas including liposarcoma, fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, and spindle cell sarcoma (93%).
- Patients must have either (1) refractory or relapsed high-risk NB (including MYCN-amplified stage 3/4/4S and MYCN-nonamplified stage 4 in patients greater than 18 months of age) resistant to standard therapy, or (2) refractory or relapsed GD2-positive tumor.
- Patients must be older than 1 year of age.
- Prior treatment with murine 3F8 is allowed. Patients with prior m3F8 or ch14.18 treatment must have HAHA antibody titer less than the upper limit of normal \[defined as mean + 3\*SD of normal volunteers\].
- Negative serum pregnancy test in women of childbearing potential.
- 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
- Existing major organ dysfunction \> grade 2, with the exception of hearing loss and myelosuppression defined as suppression of all types of WBCs, RBCs and platelets). However, the following parameters must be met: white blood cell count ≥1000/ul, absolute (neutrophil count ≥500/ul absolute lymphocyte count ≥500/ul and platelet count ≥ to 25,000/ul
- Active life-threatening infection.
- Pregnant women or women who are breast-feeding.
- Inability to comply with protocol requirements.
Key Trial Info
Start Date :
August 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01419834
Start Date
August 15 2011
End Date
August 2 2023
Last Update
August 4 2023
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065