Fenretinide in Treating Children With Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fenretinide

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