Evidence map›Paper›PMID 30014244›Full record

ArticleCancer immunology, immunotherapy : CII2018

Phase I trial of Lipovaxin-MM, a novel dendritic cell-targeted liposomal vaccine for malignant melanoma.

Tessa Gargett, M Nazim Abbas, Paul Rolan, Jason D Price, Katharine M Gosling, Antonio Ferrante, Andrew Ruszkiewicz, Ines I C Atmosukarto, Joseph Altin, Christopher R Parish and 1 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 108 citations in OpenAlex.

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  13. Nanotechnology as a Promising Method in the Treatment of Skin Cancer.International journal of molecular sciences · 2024
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  18. Nanomedicine in cancer therapy.Signal transduction and targeted therapy · 2023
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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

11 authors at 6 institutions in 1 country.

Tessa GargettCenter for Cancer Biology, University of South Australia and SA Pathology, Adelaide, SA, Australia.ORCID http://orcid.org/0000-0003-3713-1373
M Nazim AbbasCancer Clinical Trials Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.
Paul RolanSchool of Medicine, The University of Adelaide, Adelaide, SA, Australia.
Jason D PriceLipotek Pty Ltd, Canberra, ACT, Australia.
Katharine M GoslingLipotek Pty Ltd, Canberra, ACT, Australia.
Antonio FerranteSchool of Medicine, The University of Adelaide, Adelaide, SA, Australia.
Andrew RuszkiewiczCenter for Cancer Biology, University of South Australia and SA Pathology, Adelaide, SA, Australia.
Ines I C AtmosukartoLipotek Pty Ltd, Canberra, ACT, Australia.
Joseph AltinDivision of Biomedical Science and Biochemistry, Research School of Biology, Australian National University, Canberra, ACT, Australia.
Christopher R ParishACRF Department of Cancer Biology and Therapeutics, the John Curtin School of Medical Research, Australian National University, Canberra, ACT, Australia.
Michael P BrownCenter for Cancer Biology, University of South Australia and SA Pathology, Adelaide, SA, Australia. MichaelP.Brown@sa.gov.au.
Lipotek (Australia) · AUAustralian National University · AURoyal Adelaide Hospital · AUSouth Australia Pathology · AUThe University of Adelaide · AUWomen's and Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn this phase I study using a 3 + 3 dose escalation design, the safety, dose-limiting toxicity (DLT), immunogenicity and efficacy of intravenous Lipovaxin-MM-a multi-component dendritic cell-targeted liposomal vaccine against metastatic melanoma-was investigated.

methodsTwelve subjects with metastatic cutaneous melanoma were recruited in three cohorts. Patients in Cohort A (n = 3) and Cohort B (n = 3) received three doses of 0.1 and 1 mL of Lipovaxin-MM, respectively, every 4 weeks. Patients in Cohort C (n = 6) received four doses of 3 mL vaccine weekly. Immunologic assessments of peripheral blood were made at regular intervals and included leukocyte subsets, cytokine levels, and Lipovaxin-MM-specific T-cell and antibody reactivities. Tumor responses were assessed by RECIST v1.0 at screening, then 8 weekly in Cohorts A and B and 6 weekly in Cohort C.

resultsOf a total of 94 adverse events (AEs) reported in ten subjects, 43 AEs in six subjects were considered to be possibly or probably vaccine-related. Most (95%) vaccine-related AEs were grade 1 or 2, two (5%) grade 3 vaccine-related AEs of anemia and lethargy were recorded, and higher grade AEs and DLTs were not observed. No consistent evidence of vaccine-specific humoral or cellular immune responses was found in post-immunization blood samples. One patient had a partial response, two patients had stable disease, and the remaining patients had progressive disease.

conclusionsLipovaxin-MM was well tolerated and without clinically significant toxicity. Immunogenicity of Lipovaxin-MM was not detected. Partial response and stable disease were observed in one and two patients, respectively.

Indexed as

AdultAgedCancer VaccinesCutaneous Malignant MelanomaDendritic CellsDose-Response Relationship, ImmunologicFemaleHumansLiposomesMaleMelanomaMiddle AgedSkin NeoplasmsCancer VaccinesLiposomesClinical trialDC-SIGNDendritic cellsLiposomesMelanomaVaccine

Identifiers

PMID30014244
PMCPMC11028356
OpenAlexW2884957596

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.