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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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Safety/Efficacy Study |
| 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 |
|---|---|
|
ARM I: Experimental
Intravenous MAb-3F8 plus Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
|
Biological: MAb-3F8 Biological: Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) |
|
ARM II: Active Comparator
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| Contact: Mary Smith, Ph.D. | 919-425-8174 | msmith@unither.com |
| Contact: Richard E. Stark, B.Sc. | 507-536-0308 | rstark@unither.com |
| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Jessica Boklan, M.D. 602-546-0920 jboklan@phoenixchildrens.com | |
| Contact: Amanda Janitz, R.N. 602-546-0188 ajanitz@phoenixchildrens.com | |
| Principal Investigator: Jessica Boklan, M.D. | |
| United States, California | |
| Rady Children's Hospital of San Diego | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Jennifer Willert, M.D. 858-966-5811 jwillert@chsd.org | |
| Contact: Sara Hingtgen, R.N. 858-966-8381 shingtgen@chsd.org | |
| Principal Investigator: Jennifer Willert, M.D. | |
| United States, District of Columbia | |
| Georgetown Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| Contact: Corina Gonzales, M.D. 202-444-7599 gonzalec@georgetown.edu | |
| Contact: Anjum Zaki 202-687-1351 aaz2@georgetown.edu | |
| Principal Investigator: Corina Gonzales, M.D. | |
| United States, Florida | |
| All Children's Hospital in Florida | Recruiting |
| St. Petersburg, Florida, United States, 33701 | |
| Contact: Aleksandra Petrovic, M.D. 727-767-4665 petrovia@allkids.org | |
| Contact: Amber Herschberger, R.N. 727-767-4178 herschbergera@allkids.org | |
| Principal Investigator: Aleksandra Petrovic, M.D. | |
| United States, Louisiana | |
| LSU Health Sciences Center; Children's Hospital | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Lolie Yu, M.D. 504-896-9848 LYu@lsuhsc.edu | |
| Contact: Mimi Hermann, R.N. 504-894-5377 mhermann@clinicaltrialscenter.org | |
| Principal Investigator: Lolie Yu, M.D. | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Jawhar Rawwas, M.D. 612-813-5940 Jawhar.Rawwas@childrensmn.org | |
| Contact: Lezlie Rabine, R.N. 612-813-6751 Lezlie.Rabine@childrensmn.org | |
| Principal Investigator: Jawhar Rawwas, M.D. | |
| United States, New York | |
| Children's Hospital at Montefiore | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Rosanna Ricafort, M.D. 718-741-2342 rricafor@montefiore.org | |
| Contact: Catherine Stanford 718-741-2356 cstanfor@montefiore.org | |
| Principal Investigator: Rosanna Ricafort, M.D. | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Timothy Driscoll, M.D. 919-668-1100 drisc002@mc.duke.edu | |
| Contact: Caroline Peiffer, R.N. 919-668-1280 caroline.peifer@duke.edu | |
| Principal Investigator: Timothy Driscoll, M.D. | |
| United States, Ohio | |
| Nationwide Childrens Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Mark Ranalli, M.D. 614-722-3563 Mark.ranalli@nationwidechildrens.org | |
| Contact: Barb Pugh, R.N. 614-722-3568 Barbara.Pugh@nationwidechildrens.org | |
| Principal Investigator: Mark Ranalli, M.D. | |
| United States, Oklahoma | |
| University of Oklahoma Cancer Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene McNall-Knapp, M.D. 405-271-4412 Rene-McNall@ouhsc.edu | |
| Contact: Elaine Reeves, R.N. 405-271-5849 elaine-reeves@ouhsc.edu | |
| Principal Investigator: Rene McNall-Knapp, M.D. | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Contact: Jean Tersak, M.D. 412-692-5055 Jean.Tersak@chp.edu | |
| Contact: Michele Paris, R.N. 412-692-6815 michele.paris@chp.edu | |
| Principal Investigator: Jean Tersak, M.D. | |
| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Peter E. Zage, M.D. 713-792-6624 pezage@mdanderson.org | |
| Contact: MaryAnn Giannan, R.N. 713-745-0774 mgianan@mdanderson.org | |
| Principal Investigator: Peter E. Zage, M.D. | |
| US Oncology | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Stan Goldman, M.D. 972-566-6647 stan.goldman@usoncology.com | |
| Contact: Tessa Bolt, R.N. 972-566-4449 Tessa.Bolt@usoncology.com | |
| Principal Investigator: Stan Goldman, M.D. | |
| United States, Utah | |
| University of Utah Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Mark Fluchel, M.D. 801-662-4740 mark.fluchel@imail.org | |
| Contact: Stan Pies, R.N. 801-662-4715 stan.pies@imail.org | |
| Principal Investigator: Mark Fluchel, M.D. | |
| United States, Vermont | |
| Vermont Cancer Center | Recruiting |
| Burlington, Vermont, United States, 05405 | |
| Contact: Giselle Sholler, M.D. 802-847-2850 Giselle.Sholler@uvm.edu | |
| Contact: Shannon Lenox, R.N. 802-656-9283 Shannon.Lenox@med.uvm.edu | |
| Principal Investigator: Giselle Sholler, M.D. | |
| Principal Investigator: | Peter E. Zage, M.D. | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | 3F8-NB-201 |
| Study First Received: | August 31, 2009 |
| Last Updated: | December 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00969722 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neuroblastoma 3F8 Primary refractory |
|
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Neuroblastoma Keratolytic Agents Neuroectodermal Tumors Neoplasms |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Isotretinoin Tretinoin Neoplasms, Neuroepithelial Dermatologic Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |