Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors
Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors
1 other identifier
interventional
68
1 country
1
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 effects happen when higher and higher doses of a drug are used. The investigators want to find out what effects, good and/or bad, Hu3F8 has on cancer. The amount of Hu3F8 that patients gets will depend on when they start treatment on this study. The investigators also want to find out more about how Hu3F8 works and how effective it is in attacking the disease. Hu3F8 is an experimental drug, which means it has not yet been approved by the FDA for the treatment of this disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2011
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2023
CompletedAugust 4, 2023
August 1, 2023
12 years
August 17, 2011
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maximum tolerated dosage (MTD)
At least 3 patients will be studied at each dosage level and dose escalations will only be carried out if 0/3 or \< or = to 1/6 patients have dose-limiting toxicity (DLT). At least six patients will be studied at the maximum tolerated dosage (MTD).
2 years
Secondary Outcomes (3)
pharmacokinetics of hu3F8
2 years
To assess activity of hu3F8 against NB and other GD2-positive tumors.
2 years
To quantitate pain during hu3F8 treatment
2 years
Study Arms (1)
Humanized 3F8 Monoclonal Antibody (Hu3F8)
EXPERIMENTALThis phase I single arm trial assesses the toxicity of escalating doses of hu3F8.
Interventions
Hu3F8 is infused IV over \~30 minutes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Band of Parentscollaborator
- Y-mAbs Therapeuticscollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Basu, MD,PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 18, 2011
Study Start
August 15, 2011
Primary Completion
August 2, 2023
Study Completion
August 2, 2023
Last Updated
August 4, 2023
Record last verified: 2023-08