Evidence map›Paper›PMID 30012146›Full record

ArticleJournal of translational medicine2018

A Phase 1 trial of autologous monocytes stimulated ex vivo with Sylatron

Daniel S Green, Ana T Nunes, Virginia David-Ocampo, Irene B Ekwede, Nicole D Houston, Steven L Highfill, Hanh Khuu, David F Stroncek, Seth M Steinberg, Kathryn C Zoon and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02948426 (Phase 1 Study of Intraperitoneal Infusion of Autologous Monocytes With Sylatron), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT02948426 phase1terminatednot on this map

Phase 1 Study of Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2017 to 2020Enrolled18ConditionsFallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal CancerArmsAutologous Monocytes + ACTIMMUNE + SYLATRON
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Interferon-Based Therapeutics in Cancer Therapy: Past, Present, and Future.International journal of molecular sciences · 2025
    Review
  3. MHC-I-Driven Antitumor Immunity Counterbalances Low Absorbed Doses of Radiopharmaceutical Therapy.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Article
  4. Are monocytes a preferable option to develop myeloid cell-based therapies for solid tumors?Journal of experimental & clinical cancer research : CR · 2025
    Review
  5. Article
  6. Article
  7. Monocyte programming by cancer therapy.Frontiers in immunology · 2022
    Review
  8. Review
  9. Review
  10. Article
  11. Type I IFN, Ly6CMolecular cancer therapeutics · 2020
    Article
  12. Review
  13. Monocyte heterogeneity and functions in cancer.Journal of leukocyte biology · 2019
    Review
  14. 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

11 authors at 3 institutions in 1 country.

Daniel S GreenWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive RM 3B43C, Bethesda, MD, 20892, USA.
Ana T NunesWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive RM 3B43C, Bethesda, MD, 20892, USA.
Virginia David-OcampoCell Processing Section, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, USA.
Irene B EkwedeWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive RM 3B43C, Bethesda, MD, 20892, USA.
Nicole D HoustonWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive RM 3B43C, Bethesda, MD, 20892, USA.
Steven L HighfillCell Processing Section, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, USA.
Hanh KhuuCell Processing Section, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, USA.
David F StroncekCell Processing Section, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, USA.
Seth M SteinbergBiostatistics and Data Management Section, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Kathryn C ZoonLaboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, National Institutes of Health Bethesda, Bethesda, MD, USA.
Christina M AnnunziataWomen's Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive RM 3B43C, Bethesda, MD, 20892, USA. annunzic@mail.nih.gov.ORCID 0000-0003-2033-6532
National Institutes of Health · USCenter for Biologics Evaluation and Research · USNational Institutes of Health Clinical Center · US

Funding

Nuclear Factor-kappaB in Ovarian CancerZIABC011054 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ANNUNZIATA, CHRISTINA · 2009 to 2023
$12.1M
NTP INFORMATION SYSTEMS SUPPORT27305C0011 · NIEHS · Z-TECH CORPORATION · 2007 to 2009
$4.3M
Immune cell control of ovarian cancerZIABC011775 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ANNUNZIATA, CHRISTINA · 2017 to 2023
$3.6M
Clinical trials in womens cancersZIABC011584 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ANNUNZIATA, CHRISTINA · 2014 to 2023
$3.1M
PROVIDE RABBITS, RATS, MICE, HAMSTERS, GERBILS, GUINEA PIGS27307C0011 · NIEHS · PI BOLEN, WAYNE · 2007 to 2007
$500k
Development of novel cell and gene therapiesZIACL002120 · CLC · CLINICAL CENTER · PI STRONCEK, DAVID · 2009 to 2025
$0k
Intramural NIH HHS ZIA BC011054NCI NIH HHS ZIA BC 011054NIEHS NIH HHS 27305C0011NIEHS NIH HHS 27307C0011NIEHS NIH HHS 27398C0011
6 · The paper itself

Abstract

backgroundOvarian cancer has no definitive second line therapeutic options, and largely recurs in the peritoneal cavity. Locoregional immune therapy using both interferons and monocytes can be used as a novel approach. Interferons have both cytostatic and cytotoxic properties, while monocytes stimulated with interferons have potent cytotoxic properties. Due to the highly immune suppressive properties of ovarian cancer, ex vivo stimulation of autologous patient monocytes with interferons and infusion of all three agents intraperitoneally (IP) can provide a strong pro-inflammatory environment at the site of disease to kill malignant cells.

methodsPatient monocytes are isolated through counterflow elutriation and stimulated ex vivo with interferons and infused IP through a semi-permanent catheter. We have designed a standard 3 + 3 dose escalation study to explore the highest tolerated dose of interferons and monocytes infused IP in patients with chemotherapy resistant ovarian cancer. Secondary outcome measurements of changes in the peripheral blood immune compartment and plasma cytokines will be studied for correlations of response. DISCUSSION: We have developed a novel immunotherapy focused on the innate immune system for the treatment of ovarian cancer. We have combined the use of autologous monocytes and interferons alpha and gamma for local-regional administration directly into the peritoneal cavity. This therapy is highly unique in that it is the first study of its type using only components of the innate immune system for the locoregional delivery consisting of autologous monocytes and dual interferons alpha and gamma. Trial Registration ClinicalTrials.gov Identifier: NCT02948426, registered on October 28, 2016. https://clinicaltrials.gov/ct2/show/NCT02948426.

Indexed as

Dose-Response Relationship, DrugFemaleHumansInjections, IntraperitonealInterferon-alphaInterferon alpha-2Interferon-gammaMonocytesNeoplasm Recurrence, LocalOvarian NeoplasmsPolyethylene GlycolsRecombinant ProteinsTreatment OutcomeInterferon-alphaInterferon alpha-2Interferon-gammainterferon gamma-1bpeginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsCellular therapyImmunotherapyInterferonsIntraperitonealMonocytesOvarian cancer

Identifiers

PMID30012146
PMCPMC6048715
OpenAlexW2884394300

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.