A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma Or Melanoma
Relapsed and/or refractory neuroblastoma, osteosarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. Some responses have been seen in these 3 tumor types to similar antibodies.
Two schedules of hu14.18K322A antibody will be evaluated in this study, a daily for four consecutive days schedule every 28 days and a once weekly for 4 weeks schedule every 28 days. Approximately 25-40 participants will be required to define the maximum tolerated dose for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or until one or more of the criteria for off-treatment are met.
Biological: Anti-G2 antibody
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma Or Melanoma|
- Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma or melanoma. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
SJGD2 is Phase I dose finding study. The primary purpose of this phase I study is to determine maximum tolerated dose (MTD) and dose-limiting toxicity of two schedules (daily x 4 or weekly x 4) of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma or melanoma.
Initially, one research participant will be treated at the lowest dose level and if no toxicity is observed then the next participant will be treated at the next dose level. This is continued until the first instance of biological activity (in the form of grade 2 side effects) is observed and from that point on a traditional phase I study design will be followed.
Secondary objectives include:
- Estimate the response rate, within the confines of a phase I study, to the humanized anti-GD2 antibody, hu14.18K322A.
- Evaluate the pharmacokinetics of hu14.18K322A.
- Examine whether or not human anti-human antibodies (HAHA) develop in participants receiving hu14.18K322A.
- Assess the tolerability of the hu14.18K322A at the MTD of the daily x4 and the weekly dosing in patients with refractory or recurrent osteosarcoma.
|Contact: Fariba Navid, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Fariba Navid, MD email@example.com|
|Principal Investigator: Fariba Navid, MD|
|Principal Investigator:||Fariba Navid, MD||St. Jude Children's Research Hospital|