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| Sponsor: | United Therapeutics |
|---|---|
| Information provided by: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00969722 |
Purpose
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. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Refractory Neuroblastoma |
Biological: MAb-3F8 Biological: Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Biological: 13-cis-Retinoic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Study of Monoclonal Antibody 3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Compared to 13-cis-Retinoic Acid Plus GM-CSF in High Risk Stage 4, Primary Refractory Neuroblastoma Patients |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARM I
Intravenous MAb-3F8 plus Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
|
Biological: MAb-3F8 Biological: Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) |
|
Active Comparator: ARM II
Oral 13-cis-Retinoic Acid (RA) plus Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
|
Biological: Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Biological: 13-cis-Retinoic Acid |
Eligibility| Ages Eligible for Study: | 18 Months to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Rady Children's Hospital of San Diego | |
| San Diego, California, United States, 92123 | |
| United States, District of Columbia | |
| Georgetown Medical Center | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| All Children's Hospital in Florida | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Louisiana | |
| LSU Health Sciences Center; Children's Hospital | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New York | |
| Children's Hospital at Montefiore | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Nationwide Childrens Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oklahoma | |
| University of Oklahoma Cancer Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Texas | |
| US Oncology | |
| Dallas, Texas, United States, 75230 | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Vermont | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05405 | |
| Principal Investigator: | Peter E. Zage, M.D. | M.D. Anderson Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00969722 History of Changes |
| Other Study ID Numbers: | 3F8-NB-201 |
| Study First Received: | August 31, 2009 |
| Last Updated: | August 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Neuroblastoma 3F8 Primary refractory |
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Isotretinoin Tretinoin Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Keratolytic Agents |