Evidence map›Paper›PMID 25880012›Full record

Trial reportBritish journal of cancer2015

Optimizing CIGB-300 intralesional delivery in locally advanced cervical cancer.

M R Sarduy, I García, M A Coca, A Perera, L A Torres, C M Valenzuela, I Baladrón, M Solares, V Reyes, I Hernández and 14 more

Open access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.7field-weighted citation impact, top 14% 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

21 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. CK2 Chemical Probes: Past, Present, and Future.Kinases and phosphatases · 2023
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Targeting protein kinase CK2 in the treatment of cholangiocarcinoma.Exploration of targeted anti-tumor therapy · 2021
    Review
  12. Nucleophosmin in Its Interaction with Ligands.International journal of molecular sciences · 2020
    Review
  13. Article
  14. CK2-mediated CCDC106 phosphorylation is required for p53 degradation in cancer progression.Journal of experimental & clinical cancer research : CR · 2019
    Article
  15. Protein Kinase CK2, a Potential Therapeutic Target in Carcinoma ManagementAsian Pacific journal of cancer prevention : APJCP · 2019
    Review
  16. Review
  17. Article
  18. Review
  19. Article
  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

24 authors at 6 institutions in 2 countries.

M R SarduyGynecological service, Center for Medical-Surgical Research, Havana 11300, Cuba.
I GarcíaCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
M A CocaDirection for Clinical Research, Clinical Investigation Center, Havana 11300, Cuba.
A PereraDirection for Clinical Research, Clinical Investigation Center, Havana 11300, Cuba.
L A TorresDirection for Clinical Research, Clinical Investigation Center, Havana 11300, Cuba.
C M ValenzuelaCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
I BaladrónCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
M SolaresGyneco-obstetric Hospital 'Ramón González Coro', Havana 10400, Cuba.
V ReyesCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
I HernándezDeparment of Development, Isotope Center (CENTIS), Havana 11100, Cuba.
Y PereraCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
Y M MartínezGynecological service, Center for Medical-Surgical Research, Havana 11300, Cuba.
L MolinaGynecological service, Center for Medical-Surgical Research, Havana 11300, Cuba.
Y M GonzálezGynecological service, Center for Medical-Surgical Research, Havana 11300, Cuba.
J A AncízarCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
A PratsDirection for Clinical Research, Clinical Investigation Center, Havana 11300, Cuba.
L GonzálezCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
C A CasacóDirection for Clinical Research, Clinical Investigation Center, Havana 11300, Cuba.
B E AcevedoCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
P A López-SauraCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
D F AlonsoMolecular Oncology Laboratory, National University of Quilmes, Buenos Aires, Argentina.
R GómezELEA Laboratories, Buenos Aires, Argentina.
S E Perea-RodríguezCIGB-300 Research and Development Group, Laboratory of Molecular Oncology, Biomedical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Avenue 31 b/158 and 190, Cubanacán, Playa, PO Box 6162, Havana 11300, Cuba.
CERVIFARM-300-II Study Group
Centro de Ingeniería Genética y Biotecnología · CUMinisterio de Salud Pública · CUHigher Institute of Technologies and Applied Sciences · CULatin American School of Medicine · CUNational University of Quilmes · ARElea (Argentina) · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe conducted a phase 1 trial in patients with locally advanced cervical cancer by injecting 0.5 ml of the CK2-antagonist CIGB-300 in two different sites on tumours to assess tumour uptake, safety, pharmacodynamic activity and identify the recommended dose.

methodsFourteen patients were treated with intralesional injections containing 35 or 70 mg of CIGB-300 in three alternate cycles of three consecutive days each before standard chemoradiotherapy. Tumour uptake was determined using (99)Tc-radiolabelled peptide. In situ B23/nucleophosmin was determined by immunohistochemistry.

resultsMaximum tumour uptake for CIGB-300 70-mg dose was significantly higher than the one observed for 35 mg: 16.1 ± 8.9 vs 31.3 ± 12.9 mg (P = 0.01). Both, AUC24h and biological half-life were also significantly higher using 70 mg of CIGB-300 (P < 0.001). Unincorporated CIGB-300 diffused rapidly to blood and was mainly distributed towards kidneys, and marginally in liver, lungs, heart and spleen. There was no DLT and moderate allergic-like reactions were the most common systemic side effect with strong correlation between unincorporated CIGB-300 and histamine levels in blood. CIGB-300, 70 mg, downregulated B23/nucleophosmin (P = 0.03) in tumour specimens.

conclusionIntralesional injections of 70 mg CIGB-300 in two sites (0.5 ml per injection) and this treatment plan are recommended to be evaluated in phase 2 studies.

Indexed as

AdultArea Under CurveDouble-Blind MethodDown-RegulationFemaleHalf-LifeHumansInjections, IntralesionalMiddle AgedNuclear ProteinsNucleophosminPeptides, CyclicUterine Cervical NeoplasmsCIGB-300NPM1 protein, humanNuclear ProteinsNucleophosminPeptides, Cyclic

Identifiers

PMID25880012
PMCPMC4430720
OpenAlexW2073473671

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.