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| Sponsor: | St. Jude Children's Research Hospital |
|---|---|
| Information provided by (Responsible Party): | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00743496 |
Purpose
Relapsed and/or refractory neuroblastoma 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 2 tumor types to similar antibodies.
Hu14.18K322A antibody will be administered intravenously at a starting dose of 2 mg/m2 daily for 4 consecutive days. The dosage will be repeated every 28 days. Approximately 25-30 participants will be required to define the maximum tolerated dose. Participants will continue on treatment for a maximum of 4 courses or until one or more of the criteria for off-treatment are met.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma Melanoma |
Biological: Anti-G2 antibody |
Phase 1 |
| Study Type: | Interventional |
| 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 Or Melanoma |
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Anti-G2 antibody
Anti-G2 antibody
|
SJGD2 is Phase I dose finding study. The primary purpose of this phase I study is to determine maximum tolerated dose and dose-limiting toxicity 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:
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Fariba Navid, MD | info@stjude.org |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Fariba Navid, MD info@stjude.org | |
| Principal Investigator: Fariba Navid, MD | |
| Principal Investigator: | Fariba Navid, MD | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00743496 History of Changes |
| Other Study ID Numbers: | SJGD2 |
| Study First Received: | August 27, 2008 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Melanoma Neuroblastoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |