ArticlePediatric blood & cancer2013
Phase I trial of fenretinide delivered orally in a novel organized lipid complex in patients with relapsed/refractory neuroblastoma: a report from the New Approaches to Neuroblastoma Therapy (NANT) consortium.
Article in Pediatric blood & cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
47 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.
- Retinoic acid postconsolidation therapy for high-risk neuroblastoma patients treated with autologous haematopoietic stem cell transplantation.The Cochrane database of systematic reviews · 2017Pooled it
- Results of a phase I-II study of fenretinide and rituximab for patients with indolent B-cell lymphoma and mantle cell lymphoma.British journal of haematology · 2017Trial
- Cytotoxic and Cytostatic Effects of Nanoformulated Fenretinide on MG63 Osteosarcoma Cells.Pharmaceutics · 2026Article
- Fenretinide in cancer therapy and chemoprevention: past, present and future.Cancer drug resistance (Alhambra, Calif.) · 2026Review
- High-throughput in vitro drug screening and in vivo studies identify fenretinide as a brain-penetrant DMG therapeutic.Neuro-oncology · 2025Article
- The Flavivirus Non-Structural Protein 5 (NS5): Structure, Functions, and Targeting for Development of Vaccines and Therapeutics.Vaccines · 2024Review
- Attempts to Improve Lipophilic Drugs' Solubility and Bioavailability: A Focus on Fenretinide.Pharmaceutics · 2024Review
- Retinoid Therapy for Neuroblastoma: Historical Overview, Regulatory Challenges, and Prospects.Cancers · 2024Review
- Synthesis and Biological Evaluations of Granulatamide B and its Structural Analogues.Current medicinal chemistry · 2024Article
- Increased In Vivo Exposure of N-(4-Hydroxyphenyl) Retinamide (4-HPR) to Achieve Plasma Concentrations Effective against Dengue Virus.Pharmaceutics · 2023Article
- Preparation and Characterization of Amorphous Solid Dispersions for the Solubilization of Fenretinide.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Chemoprevention of neuroblastoma: progress and promise beyond uncertainties.Journal of cancer metastasis and treatment · 2023Article
- Article
- Fenretinide in Cancer and Neurological Disease: A Two-Face Janus Molecule.International journal of molecular sciences · 2022Review
- Article
- A phase I study of intravenous fenretinide (4-HPR) for patients with malignant solid tumors.Cancer chemotherapy and pharmacology · 2021Article
- Differentiating Neuroblastoma: A Systematic Review of the Retinoic Acid, Its Derivatives, and Synergistic Interactions.Journal of personalized medicine · 2021Review
- Fenretinide Acts as Potent Radiosensitizer for Treatment of Rhabdomyosarcoma Cells.Frontiers in oncology · 2021Article
- Targeting Sphingolipids for Cancer Therapy.Frontiers in oncology · 2021Review
- Pulmonary Delivery of Fenretinide: A Possible Adjuvant Treatment In COVID-19.International journal of molecular sciences · 2020Review
Corrections and comments
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Authors and funding
15 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundA phase I study was conducted to determine the maximum-tolerated dose, dose-limiting toxicities (DLTs), and pharmacokinetics of fenretinide (4-HPR) delivered in an oral powderized lipid complex (LXS) in patients with relapsed/refractory neuroblastoma. PROCEDURE: 4-HPR/LXS powder (352-2,210 mg/m(2) /day) was administered on Days 0-6, in 21-day courses, by standard 3 + 3 design.
resultsThirty-two patients (median age = 8 years, range 3-27 years) enrolled with 30 evaluable for dose escalation. Prior therapies included stem cell transplantation/support (n = 26), 13-cis-retinoic acid (n = 22), (125/131) I-MIBG (n = 13), and anti-GD2 antibody (n = 6). 170+ courses were delivered. Course 1 DLTs were a Grade 3 (n = 1) alkaline phosphatase at 352 mg/m(2) /day. Other major toxicities were Grade 4 (n = 1) alkaline phosphatases on Courses 5 and 6 at 774 mg/m(2) /day, and Grade 3 (n = 1) ALT/AST elevation on Course 2 at 1,700 mg/m(2) /day. Of 29 response-evaluable patients, six had stable disease (SD) (4-26 courses); four with marrow- or bone disease-only had complete responses (CR) (10-46 courses). 4-HPR plasma levels were several folds higher (P < 0.05) than previously reported using capsular fenretinide. The Day 6 mean peak 4-HPR plasma level at 1,700 mg/m(2) /day was 21 µM. An MTD was not reached.
conclusions4-HPR/LXS oral powder obtained higher plasma levels, with minimal toxicity and evidence of anti-tumor activity, than a previous capsule formulation. A recommended phase II schedule of 4-HPR/LXS powder is 1,500 mg/m(2) /day, TID, on Days 0-6, of a 21-day course.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.