Fenretinide in Treating Children With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003191
First received: November 1, 1999
Last updated: February 6, 2013
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: fenretinide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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):

Enrollment: 18
Study Start Date: March 1998
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: fenretinide

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.

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
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.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003191     History of Changes
Other Study ID Numbers: NCI-2012-02262, CCG-09709, CDR0000066023
Study First Received: November 1, 1999
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 16, 2014