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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center AstraZeneca |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00533169 |
Purpose
Primary Objective
Secondary Objective
To assess progression-free survival (PFS) and objective tumor response rates in children with relapsed and refractory neuroblastoma treated with ZD6474
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: ZD6474 Drug: Retinoic Acid |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of ZD6474 (Zactima) Alone and in Combination With Retinoic Acid in Relapsed and Refractory Pediatric Neuroblastoma |
| Estimated Enrollment: | 84 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Part A = ZD6474 Alone; Part B, C = ZD6474 + Retinoic Acid
|
Drug: ZD6474
Part A = Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = Starting dose 50 mg/m^2 by mouth daily on days 2-28.
Drug: Retinoic Acid
Part B, C = 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter E. Zage, MD, PhD | 713-792-6624 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Peter E. Zage, MD, PhD | |
| Principal Investigator: | Peter E. Zage, MD, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Peter E. Zage, MD, PhD/Assistant Professor ) |
| Study ID Numbers: | 2006-0807 |
| Study First Received: | September 19, 2007 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00533169 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Neuroblastoma ZD6474 Zactima Isotretinoin |
13-Cis Retinoic Acid Accutane Pediatric Neuroblastoma |
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Keratolytic Agents Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Isotretinoin |
Tretinoin Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Neuroblastoma Neoplasms, Glandular and Epithelial |
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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 |