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A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors


Phase 1
N/A
21 Years
Not Enrolling
Both
Neuroblastoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Judith G. Villablanca, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02262

NCT ID:

NCT00003191

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Neuroblastoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • recurrent neuroblastoma
  • unspecified childhood solid tumor, protocol specific
  • Neuroblastoma
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100