A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
Age
1–13
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a diagnosis of stage 4 neuroblastoma diagnosed in accordance with the International Neuroblastoma Staging System: either (a) histologic confirmation which may involve immunohistochemical, ultrastructural, and/or cytogenetic studies, or (b) elevated urinary catecholamines plus tumor cells/clumps in the bone marrow.
Have evaluable disease or biopsy-proven stable disease in BM by histology or MIBG scan with MIBG-positive disease confined to the bone or bone marrow, plus urine catecholamine results, documented \>3 weeks after conventional chemotherapy or \>6 weeks after stem-cell transplantation. CT, MRI, or bone scan (if necessary) can be done at 2-3 weeks after conventional chemotherapy confirming that the chemotherapy, radiotherapy, and ABMT are not realistic curative options.
Be between 18 months to 13 years old at diagnosis.
Have recovered to grade 2 or better toxicities since their prior therapy.
Must, if female of childbearing potential, be willing to use two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening and monthly thereafter through the first four cycles of treatment.
Have a performance score of at least 60 from Lansky Play Performance Scale if aged up to 16 years or at least 60 from Karnofsky Scale if aged more than 16 years.
Have voluntarily agreed to participate.
You may not be if
Have measurable disease ≥ 1 cm assessed by CT or MRI.
Have progressive disease (any new lesion; increase of any measurable lesion by \>25%; or previous negative marrow positive for tumor).
Have disease detectable in CNS (confirmed by CT or MRI of the brain at screening or within 8 weeks of randomization).
Be receiving alternative therapy for the treatment of neuroblastoma, e.g. radiotherapy or chemotherapy within 3 weeks of randomization.
Require additional therapy (such as radiotherapy) during the first two treatment cycles.
Have detectable human anti-mouse antibody titers at screening.
Have received prior anti-GD2 investigational therapies.
Have a history of allergies to mouse proteins.
Have an active infection requiring IV infusion of antibiotics.
Be currently receiving long-term chronic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
Clareo Health | A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
