Evidence map›Paper›PMID 9108457›Full record

Trial reportCancer research1997

Bioactivity of autologous irradiated renal cell carcinoma vaccines generated by ex vivo granulocyte-macrophage colony-stimulating factor gene transfer.

J W Simons, E M Jaffee, C E Weber, H I Levitsky, W G Nelson, M A Carducci, A J Lazenby, L K Cohen, C C Finn, S M Clift and 9 more

Abstract readClinical TrialClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Cancer research, 1997. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 1 pooled it
16.2field-weighted citation impact, top 1% 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

98 citing papers in PubMed, 1 synthesis or guideline pooled it, 413 citations in OpenAlex.

  1. Immunotherapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2017
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38 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

19 authors at 6 institutions in 1 country.

J W SimonsDepartment of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA.
E M Jaffee
C E Weber
H I Levitsky
W G Nelson
M A Carducci
A J Lazenby
L K Cohen
C C Finn
S M Clift
K M Hauda
L A Beck
K M Leiferman
A H Owens
S Piantadosi
G Dranoff
R C Mulligan
D M Pardoll
F F Marshall
Johns Hopkins University · USDana-Farber Cancer Institute · USHarvard University Press · USJohns Hopkins Medicine · USMayo Clinic · USUniversity of Alabama at Birmingham · US

Funding

STEROID MECHANISMS IN CUTANEOUS ALLERGIC INFLAMMATIONK11AI001226 · NIAID · JOHNS HOPKINS UNIVERSITY · PI BECK, LISA ANN · 1994 to 1998
–
NIAID NIH HHS K11 AI001226
6 · The paper itself

Abstract

Granulocyte-macrophage colony-stimulating factor (GM-CSF) gene-transduced, irradiated tumor vaccines induce potent, T-cell-mediated antitumor immune responses in preclinical models. We report the initial results of a Phase I trial evaluating this strategy for safety and the induction of immune responses in patients with metastatic renal cell carcinoma (RCC). Patients were treated in a randomized, double-blind dose-escalation study with equivalent doses of autologous, irradiated RCC vaccine cells with or without ex vivo human GM-CSF gene transfer. The replication-defective retroviral vector MFG was used for GM-CSF gene transfer. No dose-limiting toxicities were encountered in 16 fully evaluable patients. GM-CSF gene-transduced vaccines were equivalent in toxicity to nontransduced vaccines up to the feasible limits of autologous tumor vaccine yield. No evidence of autoimmune disease was observed. Biopsies of intradermal sites of injection with GM-CSF gene-transduced vaccines contained distinctive macrophage, dendritic cell, eosinophil, neutrophil, and T-cell infiltrates similar to those observed in preclinical models of efficacy. Histological analysis of delayed-type hypersensitivity responses in patients vaccinated with GM-CSF-transduced vaccines demonstrated an intense eosinophil infiltrate that was not observed in patients who received nontransduced vaccines. An objective partial response was observed in a patient treated with GM-CSF gene-transduced vaccine who displayed the largest delayed-type hypersensitivity conversion. No replication-competent retrovirus was detected in vaccinated patients. This Phase I study demonstrated the feasibility, safety, and bioactivity of an autologous GM-CSF gene-transduced tumor vaccine for RCC patients.

Indexed as

Gene Transfer TechniquesAdultAgedCancer VaccinesCarcinoma, Renal CellDefective VirusesDouble-Blind MethodDrug EruptionsFemaleGenetic VectorsGranulocyte-Macrophage Colony-Stimulating FactorHumansHypersensitivity, DelayedKidney NeoplasmsMaleMiddle AgedCancer VaccinesGranulocyte-Macrophage Colony-Stimulating Factor

Identifiers

PMID9108457
PMCPMC4084516
OpenAlexW1610624614

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.