Evidence map›Paper›PMID 24464266›Full record

Trial reportInvestigational new drugs2014

Phase II trial of vorinostat in advanced melanoma.

N B Haas, I Quirt, S Hotte, E McWhirter, R Polintan, S Litwin, P D Adams, T McBryan, L Wang, L P Martin and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00121225 (A Phase II Study of Vorinostat in Patients With Advanced Melanoma), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

NCT00121225 phase2completednot on this map

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2005 to 2013Enrolled32ConditionsCiliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Uveal MelanomaArmsvorinostat
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 69 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Therapeutic Targeting of Hypoxia-Inducible Factors in Cancer.International journal of molecular sciences · 2024
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Gain of Function (GOF) Mutant p53 in Cancer-Current Therapeutic Approaches.International journal of molecular sciences · 2022
    Review
  14. Review of potential medical treatments for middle ear cholesteatoma.Cell communication and signaling : CCS · 2022
    Review
  15. Review
  16. 3D modelling of γδ T-cell immunotherapy.Clinical and translational medicine · 2022
    Article
  17. Review
  18. Review
  19. Review
  20. 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

14 authors at 5 institutions in 3 countries.

N B HaasUniversity of Pennsylvania, Philadelphia, PA, USA, naomi.haas@uphs.upenn.edu.
I Quirt
S Hotte
E McWhirter
R Polintan
S Litwin
P D Adams
T McBryan
L Wang
L P Martin
M vonMehren
R K Alpaugh
J Zweibel
A Oza
Fox Chase Cancer Center · USPrincess Margaret Cancer Centre · CAJuravinski Cancer Centre · CAUniversity of Glasgow · GBAIDS Clinical Trials Group · US

Funding

Cancer Research UK 16566NCI NIH HHS HHSN261201100032C
6 · The paper itself

Abstract

introductionVorinostat is a small molecule inhibitor of class I and II histone deacetylases with preclinical activity in melanoma.

methodsWe evaluated 32 patients with advanced primary cutaneous or ocular melanoma in a multi-institutional setting (PMH Phase II Consortium) with continuous daily oral vorinostat 400 mg. The primary endpoint was response rate by RECIST, with time to progression as a secondary endpoint. The study was designed to distinguish a response rate of 20 % from a RR of 5 % and to distinguish a 2 month median progression-free survival (PFS), from one of 3.1 months. The study proceeded to stage 2 following 2 of 16 responses.. We also assessed VEGF, FGF levels, P52 polymorphisms and chromatin-associated proteins as potential biomarkers.

resultsTherapy was associated with significant side effects, including fatigue, nausea, lymphopenia, and hyperglycemia. Eleven patients experienced at least one grade 3 or higher adverse event. There were two confirmed PRs in patients with cutaneous melanoma. Sixteen patients had stable disease and 14 patients had progressive disease for best response. In addition, two patients with cutaneous melanoma scored as stable disease had early unconfirmed partial responses with subsequent progression. Patients with stable disease or partial response (n = 18) had a median progression free survival of 5 months. (range 2-12 months).

conclusionsVorinostat demonstrated some early responses and a high proportion of patients with stable disease, but did not meet its primary endpoint of response. Different schedules of this agent with BRAF mutation status and markers of histone acetylation could be explored in melanoma.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBiomarkersCutaneous Malignant MelanomaDisease-Free SurvivalFemaleFibroblast Growth FactorsHistone Deacetylase InhibitorsHistonesHumansHydroxamic AcidsMaleMelanomaMiddle AgedAntineoplastic AgentsBiomarkersFibroblast Growth FactorsHistone Deacetylase InhibitorsHistonesHydroxamic AcidsmacroH2A histoneTumor Suppressor Protein p53Vascular Endothelial Growth Factor AVEGFA protein, humanVorinostat

Identifiers

PMID24464266
OpenAlexW1977529605

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.