Evidence map›Paper›PMID 15937544›Full record

Trial reportThe Journal of clinical investigation2005

Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma.

Howard L Kaufman, Gail Deraffele, Josephine Mitcham, Dorota Moroziewicz, Seth M Cohen, Karl S Hurst-Wicker, Ken Cheung, David S Lee, Joseph Divito, Magalese Voulo and 7 more

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

Trial report in The Journal of clinical investigation, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004148 (A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma), which is not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
4.6field-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.

NCT00004148 phase1completednot on this map

A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran1999Enrolled12ConditionsMelanoma (Skin)Armsrecombinant vaccinia-B7.1 vaccine
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 145 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Immunotherapy and delivery systems for melanoma.Human vaccines & immunotherapeutics · 2024
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. 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

17 authors at 1 institution in 1 country.

Howard L KaufmanDepartment of Surgery, Columbia University, New York, NY 10032, USA. hlk2003@columbia.edu
Gail Deraffele
Josephine Mitcham
Dorota Moroziewicz
Seth M Cohen
Karl S Hurst-Wicker
Ken Cheung
David S Lee
Joseph Divito
Magalese Voulo
Julie Donovan
Kate Dolan
Kelledy Manson
Dennis Panicali
Ena Wang
Heidi Hörig
Francesco M Marincola
Columbia University · US

Funding

ZOLEDRONIC ACID IN PROSTATE CANCERM01RR000645 · NCRR · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI COLTEN, HARVEY R · 1985 to 2006
$27.0M
Immunogenetics of Vaccine TherapyZ01CL002115 · CLC · CLINICAL CENTER · PI MARINCOLA, FRANCESCO M · 2003 to 2005
–
NCRR NIH HHS M01 RR000645NCRR NIH HHS RR00645PHS HHS R01 93696
6 · The paper itself

Abstract

Immunotherapy for the treatment of metastatic melanoma remains a major clinical challenge. The melanoma microenvironment may lead to local T cell tolerance in part through downregulation of costimulatory molecules, such as B7.1 (CD80). We report the results from the first clinical trial, to our knowledge, using a recombinant vaccinia virus expressing B7.1 (rV-B7.1) for monthly intralesional vaccination of accessible melanoma lesions. A standard 2-dose-escalation phase I clinical trial was conducted with 12 patients. The approach was well tolerated with only low-grade fever, myalgias, and fatigue reported and 2 patients experiencing vitiligo. An objective partial response was observed in 1 patient and disease stabilization in 2 patients, 1 of whom is alive without disease 59 months following vaccination. All patients demonstrated an increase in postvaccination antibody and T cell responses against vaccinia virus. Systemic immunity was tested in HLA-A*0201 patients who demonstrated an increased frequency of gp100 and T cells specific to melanoma antigen recognized by T cells 1 (MART-1), also known as Melan-A, by ELISPOT assay following local rV-B7.1 vaccination. Local immunity was evaluated by quantitative real-time RT-PCR, which suggested that tumor regression was associated with increased expression of CD8 and IFN-gamma. The local delivery of vaccinia virus expressing B7.1 was well tolerated and represents an innovative strategy for altering the local tumor microenvironment in patients with melanoma.

Indexed as

Genetic TherapyImmunotherapyAdultAgedAntigens, NeoplasmB7-1 AntigenCD8 AntigensFemaleGene ExpressionHLA-A2 AntigenHLA-A AntigensHumansInjections, IntralesionalInterferon-gammaInterleukin-10MaleAntigens, NeoplasmB7-1 AntigenCD8 AntigensHLA-A*02:01 antigenHLA-A2 AntigenHLA-A AntigensInterferon-gammaInterleukin-10MART-1 AntigenMLANA protein, humanNeoplasm Proteins

Identifiers

PMID15937544
PMCPMC1142116
OpenAlexW2150755101

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.