Trial Search Results
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
The purpose of this study is to characterize the safety, tolerability, dose-limiting toxicities, and maximum tolerated dose of intravenously administered MGA271 antibody, when given weekly to children and young adults. These patients have been identified as eligible patients because they have relapsed or refractory malignant solid tumors expressing the B7-H3 surface antigen.
Stanford is currently accepting patients for this trial.
- Drug: Enoblituzumab
General Inclusion Criteria:
- Age at treatment 1 to 35 years.
- Relapsed or refractory malignant solid tumors of any histology for which no standard
curative therapy is available (escalation phase).
- Histologically proven: neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/
primitive neuroectodermal tumor, Wilms tumor, desmoplastic small round cell tumor or
malignant solid tumors of any other histology that test positive for B7-H3 .
- Must have malignant solid tumors that demonstrate B7-H3 expression at 2+ or greater
levels on the membranous surface of at least 10% of tumor cells or ≥ 25% of tumor
vasculature by IHC.
- With the exception of patients with non-measurable neuroblastoma patients must have
measurable disease as per RECIST 1.1
- Karnofsky (patients > 16 years)/Lansky (patients ≤ 16 years) index ≥ 70.
- Acceptable laboratory parameters and adequate organ reserve.
- Patients are to be excluded from the study if they have any of the following:
- Patients with a history of symptomatic central nervous system (CNS) unless they have
been treated and are asymptomatic.
- Patients with any history of known or suspected autoimmune disease with the specific
exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring
systemic treatment within the past 2 years, and patients with a history of Grave's
disease that are now euthyroid clinically and by laboratory testing.
- History of prior allogeneic bone marrow/stem-cell or solid organ transplantation.
- Patients receiving autologous stem cell transplantation must wait 8 weeks before
initiation of study drug administration.
- Treatment with systemic chemotherapy or investigational therapy within 4 weeks of
first study drug administration; other agents (e.g., biologics) within 2 weeks;
radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior
to the initiation of study drug administration; corticosteroids (≥ 0.2 mg/kg/day
prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior
to the initiation of study drug administration.
- History of clinically significant cardiovascular disease
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment
within 7 days prior to the initiation of study drug.
- Known positive testing for human immunodeficiency virus or history of acquired immune
- Known history of hepatitis B or hepatitis C infection or known positive test for
hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain
- Second primary invasive malignancy that has not been in remission for greater than 2
- History of severe trauma or major surgery within 4 weeks prior to the initiation of
study drug administration.
- Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient
contained in the drug formulation for enoblituzumab
- Patients in Canada may not have a history or evidence of latent or active tuberculosis
Ages Eligible for Study
1 Year - 35 Years
Genders Eligible for Study