|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Ariad Pharmaceuticals Pediatric Cancer Foundation University of Colorado at Denver and Health Sciences Center All Children's Hospital Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00704054 |
Purpose
Deforolimus is an mTOR inhibitor shown to have promising activity in adults with a variety of solid malignancies, particularly the sarcomas. To date, no studies to evaluate appropriate dosing or to obtain pharmacokinetic data in pediatric patients have been conducted. Sarcomas are the second most common solid malignancies in children and young adults, and for those patients with recurrent or refractory disease, new therapies are needed. This initial evaluation of deforolimus will help define appropriate dosing and toxicity evaluations, as well as establish the first pharmacokinetic and biologic correlative data in pediatric patients treated with deforolimus.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Lymphoma |
Drug: Deforolimus |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Multi-Center Phase I Study of AP23573 in Pediatric Patients With Advanced Solid Tumors |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Open label, 3+3 design, phase I dose escalation trial to determine the safety, tolerability, and MTD of deforolimus
|
Drug: Deforolimus
Initially, 3 patients will be enrolled at the first dose level (DL1—8mg/m2 up to 10mg maximum). If 1 of the 3 patients experiences a DLT, then up to 3 additional patients will be enrolled into that cohort. If <2 of 6 patients experience DLT, then dose escalation will proceed to the next dose level. If >2 of 3-6 patients experience DLT, then that dose will be declared toxic and the dose level below will be declared the MTD. In the absence of exceeding the MTD definition (see below), enrollment into the subsequent dose level will proceed only after all 3-6 patients have completed Cycle 1 of study treatment.
|
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Georgina Perez-Lewis, BA, CCRP | 813-745-7412 | Georgina.Perez-Lewis@moffitt.org |
| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Dr. Jessica Boklan, M.D. 602-546-0920 jboklan@phoenixchildrens.com | |
| United States, California | |
| City of Hope National Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Dr. Richard Jove, M.D. 626-301-8179 rjove@coh.org | |
| United States, Colorado | |
| The Children's Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Dr. Lia Gore, MD 720-777-4159 lia.gore@UCHSC.edu | |
| United States, Florida | |
| All Children's Hospital | Recruiting |
| St. Petersburg, Florida, United States, 33701 | |
| Contact: Dr. Michael Nieder, MD 727-767-6856 NiederM@allkids.org | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Dr. Amy Smith, M.D. 352-392-8724 smithaa@peds.ufl.edu | |
| Nemours Children's Clinics | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Dr. Scott Bradfield, M.D. 904-390-3652 sbradfie@nemours.org | |
| United States, Georgia | |
| Children's Healthcare of Atlanta at Egleston | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Dr. Howard Katzenstein, MD 404-785-0906 howard.katzenstein@choa.org | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Dr. Tanya M Trippett, M.D. 212-639-8267 trippet1@mskcc.org | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Dr. Cynthia Herzog, M.D. 713-745-0157 cherzog@mdanderson.org | |
| Canada, Alberta | |
| Southern Alberta Children's Cancer Program | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Dr. Aru Narendran, M.D. 403-521-3787 anarendr@ucalgary.ca | |
| Principal Investigator: | Michael Nieder, MD | All Children's Hospital |
| Principal Investigator: | Lia Gore, MD | University of Colorado at Denver and Health Sciences Center |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Douglas Letson, MD ) |
| Study ID Numbers: | SUN08-01 |
| Study First Received: | June 23, 2008 |
| Last Updated: | June 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00704054 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pediatric Solid Tumor CNS Tumor Lymphoma |
|
Lymphatic Diseases Immunoproliferative Disorders Central Nervous System Neoplasms Lymphoproliferative Disorders Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |