Evidence map›Paper›PMID 15744595›Full record

Trial reportInvestigational new drugs2005

Phase II trial of fenretinide in advanced renal carcinoma.

Ulka Vaishampayan, Lance K Heilbrun, Ralph E Parchment, Vikash Jain, James Zwiebel, Ramesh R Boinpally, Patricia LoRusso, Maha Hussain

Registry-linked trialAbstract readClinical TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00011973 (A Phase Two Study Of Fenretinide In Renal Cell Cancer), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT00011973 phase2completednot on this map

A Phase Two Study Of Fenretinide In Renal Cell Cancer

TypeinterventionalSponsorBarbara Ann Karmanos Cancer InstituteRan2000 to 2005ConditionsKidney CancerArmsfenretinide
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 58 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Targeting lipid metabolism in metastatic prostate cancer.Therapeutic advances in medical oncology · 2023
    Review
  10. Fenretinide in Cancer and Neurological Disease: A Two-Face Janus Molecule.International journal of molecular sciences · 2022
    Review
  11. Targeting Sphingolipids for Cancer Therapy.Frontiers in oncology · 2021
    Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Formulation and evaluation of biodegradable nanoparticles for the oral delivery of fenretinide.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2015
    Article
  20. Article
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

8 authors at 4 institutions in 1 country.

Ulka VaishampayanDivision of Oncology, Wayne State University/Karmanos Cancer Institute, Detroit, MI, USA.
Lance K Heilbrun
Ralph E Parchment
Vikash Jain
James Zwiebel
Ramesh R Boinpally
Patricia LoRusso
Maha Hussain
The Barbara Ann Karmanos Cancer Institute · USWayne State University · USNational Cancer Institute · USUniversity of Michigan–Ann Arbor · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Julie Lynn Boerner · 1985 to 2026
$68.4M
PHASE I TRIALS OF NEW ANTICANCER AGENTSU01CA062487 · NCI · WAYNE STATE UNIVERSITY · PI LORUSSO, PATRICIA M. · 1994 to 2013
$8.4M
NCI NIH HHS CA-22453NCI NIH HHS U01-CA-062487
6 · The paper itself

Abstract

purposeFenretinide, a synthetic form of retinoid, induced apoptosis even in chemotherapy resistant cell lines. A phase II study was hence conducted to evaluate toxicity and efficacy of fenretinide in metastatic renal cancer.

methodsEligibility included unresectable or metastatic renal cell carcinoma (RCC), adequate organ function and Zubrod performance status < or =2. Prior immunotherapy and a maximum of one prior chemotherapy regimen were allowed. Fenretinide was administered at a dose of 900 mg/m(2) twice daily orally for 7 days in a 21-day cycle. Toxicity was assessed at the start of each cycle, and response every 2 cycles.

resultsNineteen eligible patients enrolled of which fifteen had visceral/bone metastases. Seventeen patients had prior nephrectomy and 11 had prior immunotherapy. 76 cycles of therapy were delivered. Therapy was very well tolerated with few severe toxicities consisting of thrombosis in 1 individual and grade 3 fatigue, nausea and diarrhea in 1 patient. 5 patients had grade 2 nyctalopia and 3 patients had transient grade 2 visual toxicity. No objective responses were noted. Stable disease was seen in seven of nineteen cases (37%, 90% C.I. 0.21-0.59). Median time to progression was 1.5 months and median duration of stable disease was 5.8 months (90% C.I. 3.0-8.4). Median survival was 10 months. Tumor fenretinide levels were obtained in three patients and were in the lower end of the therapeutic range.

conclusionFenretinide was well tolerated but demonstrated minimal activity that was consistent with results of intratumoral drug measurements. Strategies are needed that will increase systemic and tumor levels of fenretinide.

Indexed as

Administration, OralAdultAgedAntineoplastic AgentsFemaleFenretinideHumansKidney NeoplasmsMaleMiddle AgedAntineoplastic AgentsFenretinide

Identifiers

PMID15744595
OpenAlexW2158847914

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.