Study Results
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Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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Detailed Description
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I. Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors.
II. Determine the toxicities of HPR in these patients. III. Determine the pharmacokinetics of HPR in these patients. IV. Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study.
V. Determine the effect of HPR on plasma retinol levels in these patients. VI. Determine the activity of HPR in these patients. VII. Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma.
OUTLINE: This is a dose escalation study.
Patients 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.
Patients are followed until death.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Patients 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.
fenretinide
Interventions
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fenretinide
Eligibility Criteria
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Inclusion Criteria
* Age: Under 21 at diagnosis
* Performance status: CCG 0-2
* Life expectancy: At least 2 months
* Absolute neutrophil count at least 750/mm3
* Platelet count at least 50,000/mm3
* Hemoglobin at least 7.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT less than 2.5 times normal
* Creatinine no greater than 1.5 g/dL OR creatinine clearance at least 50 mL/min OR radioisotope GFR at least 50 mL/min
* Seizure disorders controlled with anticonvulsants allowed
* No CNS toxicity greater than grade 2
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* At least 1 month since prior autologous stem cell transplantation
* No prior allogeneic transplantation
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered
* No other concurrent chemotherapy
* No concurrent immunomodulating agents (including steroids)
* Concurrent corticosteroid therapy for increased intracranial pressure allowed
* Concurrent dexamethasone for CNS tumor allowed
* At least 2 weeks since prior radiotherapy
* Concurrent radiotherapy to localized lesions allowed
* At least 2 weeks since prior retinoids Prior isotretinoin or 9-cis-retinoic acid allowed
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Judith G. Villablanca, MD
Role: STUDY_CHAIR
Children's Hospital Los Angeles
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Countries
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References
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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.
Villablanca 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.
Other Identifiers
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CCG-09709
Identifier Type: -
Identifier Source: secondary_id
CDR0000066023
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02262
Identifier Type: -
Identifier Source: org_study_id
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