Evidence map›Paper›PMID 22021066›Full record

Trial reportCancer immunology, immunotherapy : CII2012

Phase I/II randomized trial of dendritic cell vaccination with or without cyclophosphamide for consolidation therapy of advanced ovarian cancer in first or second remission.

Christina S Chu, Jean Boyer, Daniel S Schullery, Phyllis A Gimotty, Victoria Gamerman, James Bender, Bruce L Levine, George Coukos, Stephen C Rubin, Mark A Morgan and 2 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% 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

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 116 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
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  18. Cell therapies in ovarian cancer.Therapeutic advances in medical oncology · 2021
    Review
  19. Immuno-Oncology for Gynecologic Malignancies.Advances in experimental medicine and biology · 2021
    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

12 authors at 4 institutions in 1 country.

Christina S ChuDepartment of Obstetrics and Gynecology and Ovarian Cancer Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA Christina.Chu@uphs.upenn.edu
Jean Boyer
Daniel S Schullery
Phyllis A Gimotty
Victoria Gamerman
James Bender
Bruce L Levine
George Coukos
Stephen C Rubin
Mark A Morgan
Robert H Vonderheide
Carl H June
University of Pennsylvania · USCancer Research Center · USFox Chase Cancer Center · USImmunoCellular Therapeutics (United States) · US

Funding

Therapeutic Micro RNA Strategies for Ovarian CancerP50CA083638 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GODWIN, ANDREW K., GOLEMIS, ERICA A. · 1999 to 2013
$33.6M
Cancer Biostatistics Training GrantT32CA093283 · NCI · UNIVERSITY OF PENNSYLVANIA · PI GIMOTTY, PHYLLIS A. · 2003 to 2012
$1.7M
Phase 1 Trial of Anti-Mesothelin Chimeric ImmunoreceptorR21CA115049 · NCI · UNIVERSITY OF PENNSYLVANIA · PI CHU, CHRISTINA S · 2006 to 2007
$541k
NCI NIH HHS 5P50CA083638NCI NIH HHS P50 CA083638NCI NIH HHS R21 CA115049NCI NIH HHS R21CA115049NCI NIH HHS T32 CA093283NCI NIH HHS T32CA093283
6 · The paper itself

Abstract

purposeIn spite of increased rates of complete response to initial chemotherapy, most patients with advanced ovarian cancer relapse and succumb to progressive disease. Immunotherapy may have potential for consolidation therapy. EXPERIMENTAL

designThis randomized open-label phase I/II trial evaluated responses of patients with advanced ovarian cancer in remission for vaccination with monocyte-derived dendritic cells (DC) loaded with Her2/neu, hTERT, and PADRE peptides, with or without low-dose intravenous cyclophosphamide. All patients also received pneumococcal vaccine and were randomized to cyclophosphamide 2 days prior to first vaccination. Blood samples were analyzed by ELISPOT and flow cytometry.

resultsOf 11 patients, 2 recurred during vaccination. Nine received all 4 doses: 3 patients recurred at 6, 17, and 26 months, respectively, and 6 have no evidence of disease at 36 months. No grade 3/4 vaccine-related toxicities were noted. The 3-year overall survival was 90%. Patients receiving cyclophosphamide showed a non-significant improvement in survival over controls. Patients receiving cyclophosphamide had a transient reduction in neutrophils, but no change in total lymphocytes or regulatory T cells. Modest T-cell responses to Her2/neu and hTERT were seen post-vaccine by IFN-γ ELISPOT. Patients demonstrated below normal responses to the diphtheria conjugate protein CRM197, a component of the pneumococcal vaccine.

conclusionsIn this setting, peptide-loaded DC vaccination elicits modest immune responses, but survival is promising. Pneumococcal vaccination revealed substantial immune suppression, even in patients in remission. Rational design of consolidative strategies for ovarian cancer will need to overcome tolerance and immunosuppression.

Indexed as

AdolescentAdultBacterial ProteinsCancer VaccinesCombined Modality TherapyCyclophosphamideDendritic CellsDrug SynergismErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunotherapy, AdoptiveInterferon-gammaMalaria VaccinesMiddle AgedMonocytesBacterial ProteinsCancer VaccinesCRM197 (non-toxic variant of diphtheria toxin)CyclophosphamideERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesInterferon-gammaMalaria VaccinesPADRE 45Peptide FragmentsPneumococcal Vaccines

Identifiers

PMID22021066
PMCPMC11029255
OpenAlexW1991221997

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.