Fenretinide in Treating Children With Solid Tumors
Neuroblastoma, Unspecified Childhood Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma, unspecified childhood solid tumor, protocol specific
Eligibility 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
Sites / Locations
- Cancer Center and Beckman Research Institute, City of Hope
- Long Beach Memorial Medical Center
- Children's Hospital Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital of Orange County
- UCSF Cancer Center and Cancer Research Institute
- Children's National Medical Center
- Indiana University Cancer Center
- University of Michigan Comprehensive Cancer Center
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- Children's Mercy Hospital
- Cancer Institute of New Jersey
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Children's Hospital Medical Center - Cincinnati
- Children's Hospital of Columbus
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Vanderbilt-Ingram Cancer Center
- University of Texas - MD Anderson Cancer Center
- Primary Children's Medical Center
- Children's Hospital and Regional Medical Center - Seattle
- University of Wisconsin Comprehensive Cancer Center
- Princess Margaret Hospital for Children
Arms of the Study
Arm 1
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.