Evidence map›Paper›PMID 33423090›Full record

ArticleCancer chemotherapy and pharmacology2021

A phase I study of intravenous fenretinide (4-HPR) for patients with malignant solid tumors.

Jacob S Thomas, Anthony B El-Khoueiry, Barry J Maurer, Susan Groshen, Jacek K Pinski, Everardo Cobos, David R Gandara, Heinz J Lenz, Min H Kang, C Patrick Reynolds and 1 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Sphingolipid metabolism and regulated cell death in malignant melanoma.Apoptosis : an international journal on programmed cell death · 2024
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Fenretinide in Cancer and Neurological Disease: A Two-Face Janus Molecule.International journal of molecular sciences · 2022
    Review
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Jacob S ThomasUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA. jacob.thomas@med.usc.edu.ORCID 0000-0002-8420-366X
Anthony B El-KhoueiryUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Barry J MaurerCancer Center, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
Susan GroshenUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Jacek K PinskiUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Everardo CobosUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
David R GandaraDavis Comprehensive Cancer Center, University of California, Sacramento, CA, USA.
Heinz J LenzUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Min H KangCancer Center, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
C Patrick ReynoldsCancer Center, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
Edward M NewmanCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
University of Southern California · USTexas Tech University · USCity of Hope · USUniversity of California, Davis · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
PHASE I MOLECULAR AND CLINICAL PHARMACODYNAMIC TRIALSU01CA062505 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI NEWMAN, EDWARD M · 1994 to 2013
$8.1M
NCI NIH HHS P30 CA014089NCI NIH HHS P30 CA033572NCI NIH HHS P30 CA093373NCI NIH HHS U01 CA062505NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

backgroundFenretinide is a synthetic retinoid that can induce cytotoxicity by several mechanisms. Achieving effective systemic exposure with oral formulations has been challenging. An intravenous lipid emulsion fenretinide formulation was developed to overcome this barrier. We conducted a study to establish the maximum tolerated dose (MTD), preliminary efficacy, and pharmacokinetics of intravenous lipid emulsion fenretinide in patients with advanced solid tumors.

methodsTwenty-three patients with advanced solid tumors refractory to standard treatments received fenretinide as a continuous infusion for five consecutive days in 21-day cycles. Five different dose cohorts were evaluated between doses of 905 mg/m

resultsThe treatment-related adverse events occurring in ≥ 20% of patients were anemia, hypertriglyceridemia, fatigue, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase, thrombocytopenia, bilirubin increase, and dry skin. Five evaluable patients had stable disease as best response, and no patients had objective responses. Plasma steady-state concentrations of the active metabolite were significantly higher than with previous capsule formulations.

conclusionFenretinide emulsion intravenous infusion had a manageable safety profile and achieved higher plasma steady-state concentrations of the active metabolite compared to previous capsule formulations. Single-agent activity was minimal but combinatorial approaches are under evaluation.

Indexed as

AdultAgedAged, 80 and overFemaleFenretinideHumansInfusions, IntravenousMaleMaximum Tolerated DoseMiddle AgedNeoplasmsFenretinideCeramideLipid emulsionPhase IRetinoid

Identifiers

PMID33423090
PMCPMC8058950
OpenAlexW3118863463

What OpenQuestion holds

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Registered trials

None linked

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.