Fenretinide in Treating Children With Solid Tumors
A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors
3 other identifiers
interventional
18
2 countries
26
Brief Summary
Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
November 26, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFebruary 7, 2013
August 1, 2006
7 years
November 1, 1999
February 6, 2013
Conditions
Keywords
Study Arms (1)
Arm I
EXPERIMENTALPatients receive oral fenretinide 3 times a day on days 1-7. Treatment repeats every 3 weeks for up to 8 courses. Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor. Patients with recurrent neuroblastoma, after prior myeloablative therapy with no measurable disease, will stop treatment after 8 courses. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (26)
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039, United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001, Australia
Related Publications (2)
Children's Oncology Group (CCG 09709); Villablanca JG, Krailo MD, Ames MM, Reid JM, Reaman GH, Reynolds CP. Phase I trial of oral fenretinide in children with high-risk solid tumors: a report from the Children's Oncology Group (CCG 09709). J Clin Oncol. 2006 Jul 20;24(21):3423-30. doi: 10.1200/JCO.2005.03.9271.
PMID: 16849757RESULTVillablanca JG, Ames MW, Reid JM, et al.: Phase I trial of oral [N-(-4-hydroxyphenyl)retinamide] (4-HPR) in children with resistant/recurrent solid tumors: a children's cancer group study (CCG 09709). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1588, 2002.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Judith G. Villablanca, MD
Children's Hospital Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
November 26, 2003
Study Start
March 1, 1998
Primary Completion
March 1, 2005
Last Updated
February 7, 2013
Record last verified: 2006-08