Status:
TERMINATED
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
Lead Sponsor:
United Therapeutics
Conditions:
Primary Refractory Neuroblastoma
Eligibility:
All Genders
18-13 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00969722
Start Date
August 1 2009
Last Update
March 8 2013
Active Locations (15)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Rady Children's Hospital of San Diego
San Diego, California, United States, 92123
3
Georgetown Medical Center
Washington D.C., District of Columbia, United States, 20057
4
All Children's Hospital in Florida
St. Petersburg, Florida, United States, 33701