Evidence map›Paper›PMID 18483372›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Pilot study of vaccination with recombinant CEA-MUC-1-TRICOM poxviral-based vaccines in patients with metastatic carcinoma.

James L Gulley, Philip M Arlen, Kwong-Yok Tsang, Junko Yokokawa, Claudia Palena, Diane J Poole, Cinzia Remondo, Vittore Cereda, Jacquin L Jones, Mary P Pazdur and 6 more

2 registry-linked trialsOpen access · bronzeAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 109 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 2 pooled it
6.6field-weighted citation impact, top 3% 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.

NCT00088413 phase1 / phase2completednot on this map

An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2004 to 2018Enrolled51ConditionsAdenocarcinoma, Colorectal Cancer, Ovarian Cancer, Breast CancerArmsPANVAC-V, PANVAC-F, Sargramostim (GM-CSF, Leukine)
NCT02015104 phase2completednot on this mapstarted 2013, after this paper: background citation

A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) Given in Combination With PANVAC[TM] Versus BCG Given Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) Who Failed at Least 1 Induction Course of BCG

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2019Enrolled32ConditionsBladder CancerArmsBCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)), PANVAC
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 2 syntheses or guidelines pooled it, 228 citations in OpenAlex.

  1. Pooled it
  2. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Trial
  5. Targeting Carcinoembryonic Antigen with DNA Vaccination: On-Target Adverse Events Link with Immunologic and Clinical Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
  6. Trial
  7. Trial
  8. Humoral response to a viral glycan correlates with survival on PROSTVAC-VF.Proceedings of the National Academy of Sciences of the United States of America · 2014
    Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
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49 more citing papers are in PubMed but not listed here.

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

16 authors at 1 institution in 1 country.

James L GulleyLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA.
Philip M Arlen
Kwong-Yok Tsang
Junko Yokokawa
Claudia Palena
Diane J Poole
Cinzia Remondo
Vittore Cereda
Jacquin L Jones
Mary P Pazdur
Jack P Higgins
James W Hodge
Seth M Steinberg
Herbert Kotz
William L Dahut
Jeffrey Schlom
National Cancer Institute · US

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
Vaccine and Drug Combination Therapy for Human CancersZIABC010661 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HODGE, JAMES · 2009 to 2025
$11.2M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
Identification of human tumor-associated antigensZIABC010972 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$6.0M
Analyses of human T regulatory cellsZIABC010973 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$3.7M
Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZ01BC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2005 to 2008
$2.9M
Vaccines /Vaccine Strategies for Human CancerZ01BC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2000 to 2008
$2.7M
Vaccine Clinical TrialsZ01BC010662 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ARLEN, PHILIP M · 2005 to 2008
$1.7M
BIOSTATISTICS AND DATA MANAGEMENT SECTIONZ01SC007202 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI STEINBERG, SETH M · 1996 to 2008
$1.5M
Novel Targets for Vaccine TherapyZ01BC010937 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2008 to 2008
$541k
Intramural NIH HHS Z01 BC010425
6 · The paper itself

Abstract

purposePoxviral vectors have a proven safety record and can be used to incorporate multiple transgenes. Prior clinical trials with poxviral vaccines have shown that immunologic tolerance to self-antigens can be broken. Carcinoembryonic antigen (CEA) and MUC-1 are overexpressed in a substantial proportion of common solid carcinomas. The primary end point of this study was vaccine safety, with immunologic and clinical responses as secondary end points. EXPERIMENTAL

designWe report here a pilot study of 25 patients treated with a poxviral vaccine regimen consisting of the genes for CEA and MUC-1, along with a triad of costimulatory molecules (TRICOM; composed of B7.1, intercellular adhesion molecule 1, and lymphocyte function-associated antigen 3) engineered into vaccinia (PANVAC-V) as a prime vaccination and into fowlpox (PANVAC-F) as a booster vaccination.

resultsThe vaccine was well tolerated. Apart from injection-site reaction, no grade > or =2 toxicity was seen in more than 2% of the cycles. Immune responses to MUC-1 and/or CEA were seen following vaccination in 9 of 16 patients tested. A patient with clear cell ovarian cancer and symptomatic ascites had a durable (18-month) clinical response radiographically and biochemically, and one breast cancer patient had a confirmed decrease of >20% in the size of large liver metastasis.

conclusionsThis vaccine strategy seems to be safe, is associated with both CD8 and CD4 immune responses, and has shown evidence of clinical activity. Further trials with this agent, either alone or in combination with immunopotentiating and other therapeutic agents, are warranted.

Indexed as

Adjuvants, ImmunologicAdultAgedB7-1 AntigenCancer VaccinesCarcinoembryonic AntigenCD58 AntigensFemaleGenetic VectorsHumansIntercellular Adhesion Molecule-1MaleMiddle AgedMucin-1NeoplasmsPilot ProjectsAdjuvants, ImmunologicB7-1 AntigenCancer VaccinesCarcinoembryonic AntigenCD58 AntigensIntercellular Adhesion Molecule-1MUC1 protein, humanMucin-1Vaccines, Synthetic

Identifiers

PMID18483372
PMCPMC2673097
OpenAlexW2133289699

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.