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Fenretinide in Treating Children With Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00003191   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
March 1998
 
 
 
Complete list of historical versions of study NCT00003191 on ClinicalTrials.gov Archive Site
 
 
 
Fenretinide in Treating Children With Solid Tumors
A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy.

OBJECTIVES: 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.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study in 2 years.

Phase I
Interventional
Treatment
  • Neuroblastoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: fenretinide
 
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. Erratum in: J Clin Oncol. 2006 Sep 1;24(25):4223. Reynolds, Patrick C [corrected to Reynolds, C Patrick].

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
18
 
 

DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor that is refractory to conventional therapy or recurrent neuroblastoma treated with myeloablative therapy and autologous stem cell transplant in second complete or partial response Bone marrow metastases with granulocytopenia, anemia, and/or thrombocytopenia are eligible

PATIENT CHARACTERISTICS: Age: Under 21 at diagnosis Performance status: CCG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 750/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 7.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 g/dL OR Creatinine clearance at least 50 mL/min OR Radioisotope GFR at least 50 mL/min Other: Seizure disorders controlled with anticonvulsants allowed No CNS toxicity greater than grade 2 Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior autologous stem cell transplantation No prior allogeneic transplantation Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent immunomodulating agents (including steroids) Concurrent corticosteroid therapy for increased intracranial pressure allowed Concurrent dexamethasone for CNS tumor allowed Radiotherapy: At least 2 weeks since prior radiotherapy Concurrent radiotherapy to localized lesions allowed Surgery: Not specified Other: At least 2 weeks since prior retinoids Prior isotretinoin or 9-cis-retinoic acid allowed

Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00003191
 
CDR0000066023, CCG-09709
Children's Cancer Group
National Cancer Institute (NCI)
Study Chair: Judith G. Villablanca, MD Children's Hospital Los Angeles
National Cancer Institute (NCI)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP