Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma

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

Summary

This phase II trial is studying how well fenretinide works in treating children with recurrent or resistant neuroblastoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of recurrent or resistant/refractory high-risk neuroblastoma by one or both of the following:

• Histological confirmation

• Demonstration of tumor cells in bone marrow with increased urinary catecholamines

• Stratum I:

• At least 1 unidimensionally measurable lesion*

• At least 20 mm by MRI and/or CT scan OR at least 10 mm by spiral CT scan

• Stratum II: Meets one or both of the following criteria:

• At least 1 site with positive uptake on meta-iodobenzylguanidine (MIBG) I 123 scan

• Tumor in bilateral bone marrow aspirate/biopsy by routine morphology (no NSE staining only)

• Stratum III:

• At least 5 tumor cells/10^6 mononuclear cells in the bone marrow by immunocytology only (on 2 successive bone marrows performed from 1 day to 4 weeks apart)

• Patients in first response (i.e., patients with persistent tumor at end of frontline therapy, but who have never had disease relapse or progression) must have histological* or morphological (by bone marrow) confirmation** of viable tumor on CT scan, MRI, or MIBG scan after completion of myeloablative therapy (for strata I and II)

• No catecholamine elevation only

• Performance status - 0-2

• At least 2 months

• Hemoglobin greater than 7.5 g/dL (transfusion allowed)

• Bilirubin no greater than 1.5 times normal

• SGPT and SGOT less than 2.5 times normal

• Creatinine normal for age

• No hematuria or proteinuria greater than 1+ on urinalysis

• Calcium less than 11.6 mg/dL

• Triglycerides less than 300 mg/dL

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No seizure disorders unless on anticonvulsants and well controlled

• No skin toxicity greater than grade 1

• Must be able to consume entire intact study capsule in the dosage prescribed for body surface area

• Recovered from prior immunotherapy

• At least 7 days since prior anticancer biologic therapy

• At least 2 days since prior growth factors

• Prior autologous stem cell transplantation allowed

• No prior allogeneic stem cell transplantation

• No concurrent immunomodulating agents

• At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

• No concurrent anticancer chemotherapy

• No concurrent steroids

• Recovered from prior radiotherapy

• At least 4 weeks since prior radiotherapy to target lesion

• Prior radiotherapy to non target lesions allowed

• No concurrent radiotherapy to sole measurable lesion for symptom relief

• Concurrent palliative radiotherapy to non target or localized painful lesions allowed

• Prior tretinoin or isotretinoin allowed

• At least 2 weeks since other prior retinoids

• No prior fenretinide

• No concurrent supplemental oral or IV vitamin A, ascorbic acid, or vitamin E (except if contained in routine total parenteral nutrition [TPN] vitamin supplements)

• No concurrent drugs suspected of causing pseudotumor cerebri (e.g., tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, amiodarone, or vitamin A [except as part of routine TPN supplements])

• No other concurrent anticancer agents