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Fenretinide in Treating Children With Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Children's Cancer Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003191
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: fenretinide
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 18
Study Start Date: March 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003191

  Show 26 Study Locations
Sponsors and Collaborators
Children's Cancer Group
Investigators
Study Chair: Judith G. Villablanca, MD Children's Hospital Los Angeles
  More Information

Additional Information:
Publications:
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].
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.

Study ID Numbers: CDR0000066023, CCG-09709
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003191     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent neuroblastoma
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:
Anticarcinogenic Agents
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Fenretinide
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Protective Agents
Pharmacologic Actions
Neuroblastoma
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Fenretinide
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009