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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00533169 |
Purpose
The goal of this clinical research study is to find the highest safe dose of the drug ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse, has come back, or has not responded to the treatment.
Primary Objective:
-To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated dose of ZD6474, alone in children with medulloblastoma, and alone in combination with retinoic acid, in patients with relapsed or refractory neuroblastoma.
Secondary Objective:
-To assess progression-free survival (PFS) and objective tumor response rates in children with relapsed and refractory neuroblastoma and medulloblastoma treated with ZD6474 +/- retinoic acid in the context of a Phase I trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: ZD6474 Drug: Retinoic Acid |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of ZD6474 (Zactima) Alone and in Combination With Retinoic Acid in Relapsed and Refractory Pediatric Neuroblastoma |
| Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ZD6474 + Retinoic Acid
Part A = ZD6474 Alone, Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = ZD6474 + Retinoic Acid 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
|
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.
Other Names:
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).
Other Names:
|
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| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Peter E. Zage, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00533169 History of Changes |
| Other Study ID Numbers: | 2006-0807 |
| Study First Received: | September 19, 2007 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Neuroblastoma ZD6474 Zactima Isotretinoin |
13-Cis Retinoic Acid Accutane Pediatric Neuroblastoma |
|
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 |