Evidence map›Paper›PMID 34430349›Full record

ArticleTranslational lung cancer research2021

Randomized phase II trial of a first-in-human cancer cell lysate vaccine in patients with thoracic malignancies.

Mary Zhang, Julie A Hong, Tricia F Kunst, Colleen D Bond, Cara M Kenney, Cheryl L Warga, Javier Yeray, Min-Jung Lee, Akira Yuno, Sunmin Lee and 6 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Translational lung cancer research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02054104 (Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 37% 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.

NCT02054104 phase1 / phase2terminatednot on this map

Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2015Enrolled21ConditionsThoracic Sarcomas, Thorasic Cancers, Cancers of Non-thoracic Origin With Metastases to the Lungs or Pleura, SarcomaArmsH1299 cell lysates, Cyclophosphamide, Celecoxib, Iscomatrix adjuvant
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 1 country.

Mary ZhangThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Julie A HongThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Tricia F KunstThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Colleen D BondThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Cara M KenneyThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Cheryl L WargaThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Javier YerayTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Min-Jung LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Akira YunoDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Sunmin LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Markku MiettinenLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
R Taylor RipleyThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Chuong D HoangThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Sacha GnjaticTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Jane B TrepelDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
David S SchrumpThoracic Epigenetics Section, Thoracic Surgery Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Center for Cancer Research · USNational Cancer Institute · USIcahn School of Medicine at Mount Sinai · US

Funding

High-Dimensional Immune Monitoring of NCI-Supported Immunotherapy TrialsU24CA224319 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Sacha Gnjatic, Seunghee Kim-Schulze · 2017 to 2026
$21.5M
Targeting the Epigenome for Lung Cancer TherapyZIASC010093 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI SCHRUMP, DAVID · 2009 to 2025
$11.9M
Targeting the Epigenome for the Treatment and PreventionZ01SC010093 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI SCHRUMP, DAVID · 1997 to 2008
$4.7M
Characterizing and predicting colitis in immune checkpoint blockade-treated cancer patientsU01DK124165 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI COLOMBEL, JEAN-FREDERIC, FAITH, JEREMIAH JAMES · 2020 to 2024
$2.9M
Intramural NIH HHS Z01 SC010093Intramural NIH HHS ZIA SC010093NCI NIH HHS U24 CA224319NIDDK NIH HHS U01 DK124165
6 · The paper itself

Abstract

backgroundAlthough most malignancies express cancer-testis antigens (CTA), immune responses to these proteins are limited in thoracic oncology patients. This trial was undertaken to examine if a cancer cell lysate vaccine could induce immunity to CTA, and to ascertain if metronomic cyclophosphamide and celecoxib enhances vaccine-induced immune responses.

methodsEleven patients with primary thoracic malignancies and 10 patients with extrathoracic neoplasms metastatic to the chest rendered NED by conventional therapies were randomized to receive H1299 lung cancer cell lysates (10 mg protein/vaccine) with Iscomatrix™ adjuvant via deep intradermal injection q 4 weeks ×6 with or without daily oral metronomic cyclophosphamide/celecoxib. The primary endpoint was serologic response to purified CTA assessed 1 month after the 6

resultsAll patients exhibited local and systemic inflammatory responses lasting 72-96 hours following vaccinations. There were no dose limiting treatment related toxicities. Fourteen patients (67%) completed all six vaccinations. Eight of 14 patients (57%) exhibited serologic responses to NY-ESO-1. One patient developed antibodies to GAGE7; several patients exhibited reactivity to XAGE and MAGE-C2. Vaccine therapy decreased the percent of Tregs (P=0.0068), PD-1 expression on Tregs (P=0.0027), PD-L1 expression on CD14

conclusionsH1299 lysate vaccines with Iscomatrix™ induce immune responses to CTA and modulate peripheral immune subsets in a manner that may enhance antitumor immunity in patients with thoracic malignancies.

Indexed as

cancer-testis antigenfirst-in-humanpulmonary metastasisthoracic malignancyVaccine

Identifiers

PMID34430349
PMCPMC8350099
OpenAlexW3183183523

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.