Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma

Completed · Phase 2

Conditions studied: Recurrent Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00053326

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2003-05-01

Last updated by the study team

2013-10-08

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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