Evidence map›Paper›PMID 31898184›Full record

ArticleInvestigational new drugs2020

NCI 6896: a phase I trial of vorinostat (SAHA) and isotretinoin (13-cis retinoic acid) in the treatment of patients with advanced renal cell carcinoma.

Ana M Molina, Johannes C van der Mijn, Paul Christos, John Wright, Charlene Thomas, Janice P Dutcher, David M Nanus, Scott T Tagawa, Lorraine J Gudas

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Review
  3. Histone deacetylases and their inhibitors in kidney diseases.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  4. Review
  5. Vitamin A and retinoid signaling in the kidneys.Pharmacology & therapeutics · 2023
    Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. 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

9 authors at 3 institutions in 2 countries.

Ana M MolinaDivision of Hematology/Oncology, Department of Medicine, Weill Cornell Medicine, 520 East 70th Street, New York, NY, 10021, USA. amm9052@med.cornell.edu.ORCID http://orcid.org/0000-0003-2025-9418
Johannes C van der MijnDepartment of Pharmacology, Weill Cornell Medicine, New York, NY, USA.
Paul ChristosDepartment of Biostatistics and Epidemiology, Weill Cornell Medicine, New York, NY, USA.
John WrightDivision of Cancer Treatment & Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Charlene ThomasDivision of Hematology/Oncology, Department of Medicine, Weill Cornell Medicine, 520 East 70th Street, New York, NY, 10021, USA.
Janice P DutcherOur Lady of Mercy Cancer Center, Bronx, NY, USA.
David M NanusDivision of Hematology/Oncology, Department of Medicine, Weill Cornell Medicine, 520 East 70th Street, New York, NY, 10021, USA.
Scott T TagawaDivision of Hematology/Oncology, Department of Medicine, Weill Cornell Medicine, 520 East 70th Street, New York, NY, 10021, USA.
Lorraine J GudasDepartment of Pharmacology, Weill Cornell Medicine, New York, NY, USA.
Cornell University · USKids' Brain Tumor Cure Foundation · USNational Cancer Institute · US

Funding

New York Cancer Consortium NO1-CM-62204
6 · The paper itself

Abstract

Preclinical studies suggest that histone deacetylase (HDAC) inhibitors may restore tumor sensitivity to retinoids and have synergistic anti-tumor activity when combined. We performed a Phase I clinical trial to evaluate the safety and preliminary efficacy of combining the oral HDAC inhibitor vorinostat and isotretinoin in patients with advanced renal cell carcinoma (RCC). Vorinostat was administered at 300 mg orally twice daily in combination with escalating doses of isotretinoin for 3 consecutive days per week. A standard 3 + 3 dose escalation design was used. Dose limiting toxicities (DLT) were assess during the first cycle to determine the maximum tolerated dose (MTD). Fourteen patients enrolled on the trial of which 12 were evaluable for toxicity (6 cohort 1; 3 cohort 2; 3 cohort 3) and 11 for tumor response. One patient in cohort 1 experienced a DLT (grade 3 depression). Common grade 1-2 toxicities included fatigue and GI effects (nausea, diarrhea, anorexia). MTD was established as vorinostat 300 mg with isoretinoin 0.5 mg/kg twice daily 3 days per week. Best responses in evaluable patients included 1 partial response and 9 stable disease, lasting a median of 3.7 months (range 1.8-10.4 months). The combination of vorinostat and isotretinoin is safe, tolerable and associated with responses in patients with refractory metastatic RCC.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellFemaleHumansIsotretinoinKaplan-Meier EstimateKidney NeoplasmsMaleMaximum Tolerated DoseMiddle AgedProgression-Free SurvivalVorinostatAntineoplastic AgentsIsotretinoinVorinostatHistone deacetylaseIsotretinoinRenal cell carcinomaSAHAVorinostat

Identifiers

PMID31898184
OpenAlexW2997230917

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.