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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00533169 |
Purpose
Hypothesis:
ZD6474 will have significant antitumor activity in cases of relapsed and refractory neuroblastoma due to the combined inhibition of biologically relevant RET, VEGFR, and EGFR pathways, and it will have synergistic antitumor activity in combination with retinoid therapy.
Primary Objective:
To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated dose of ZD6474, alone and 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 treated with ZD6474 +/- retinoic acid in the context of a Phase I trial.
Exploratory Objectives:
To explore blood-based biomarkers before and after treatment with ZD6474 alone and in combination with retinoic acid.
To investigate the presence, activation, and functional status of target receptors (RET, EGFR, VEGFR) and signalling pathways in archival tumor specimens when available.
| 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: | October 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00533169 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neuroblastoma ZD6474 Zactima Isotretinoin |
13-Cis Retinoic Acid Accutane Pediatric Neuroblastoma |
|
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 |