Skip to main content
Top
Published in: Investigational New Drugs 4/2016

01-08-2016 | SHORT REPORT

Why balls are not put inside the basket? A reflection on testicular cancer clinical trial design

Authors: Hampig Raphael Kourie, Fouad Aoun

Published in: Investigational New Drugs | Issue 4/2016

Login to get access

Summary

New concepts of trial design are being developed based on biomarkers, namely basket and umbrella trials. Basket trials appear optimally positioned to evaluate new molecular markers for testicular germ cell tumors, a rare heterogeneous disease with relatively few molecular alterations. However, not uncommonly, the “balls” fall outside the “basket”. In this short communication, we discussed the different causes limiting the inclusion of TGCT in basket trials and we proposed a new design for trials suitable for this malignancy.
Literature
1.
go back to reference Catenacci DV (2015) Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity. Mol Oncol 9:967–996CrossRefPubMed Catenacci DV (2015) Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity. Mol Oncol 9:967–996CrossRefPubMed
3.
go back to reference Jacobsen C, Honecker F (2015) Cisplatin resistance in germ cell tumours: models and mechanisms. Andrology 3:111–121CrossRefPubMed Jacobsen C, Honecker F (2015) Cisplatin resistance in germ cell tumours: models and mechanisms. Andrology 3:111–121CrossRefPubMed
4.
go back to reference Cavallo F, Feldman DR, Barchi M (2013) Revisiting DNA damage repair, p53-mediated apoptosis and cisplatin sensitivity in germ cell tumors. Int J Dev Biol 57:273–280CrossRefPubMed Cavallo F, Feldman DR, Barchi M (2013) Revisiting DNA damage repair, p53-mediated apoptosis and cisplatin sensitivity in germ cell tumors. Int J Dev Biol 57:273–280CrossRefPubMed
5.
go back to reference Gillis AJ, Rijlaarsdam MA, Eini R, et al. (2013) Targeted serum miRNA (TSmiR) test for diagnosis and follow-up of(testicular) germ cell cancer patients: a proof of principle. Mol Oncol 7:1083–1092CrossRefPubMed Gillis AJ, Rijlaarsdam MA, Eini R, et al. (2013) Targeted serum miRNA (TSmiR) test for diagnosis and follow-up of(testicular) germ cell cancer patients: a proof of principle. Mol Oncol 7:1083–1092CrossRefPubMed
6.
go back to reference Dieckmann KP, Spiekermann M, Balks T, et al. (2012) MicroRNAs miR-371-3 in serum as diagnostic tools in the management of testicular germ cell tumours. Br J Cancer 107:1754–1760CrossRefPubMedPubMedCentral Dieckmann KP, Spiekermann M, Balks T, et al. (2012) MicroRNAs miR-371-3 in serum as diagnostic tools in the management of testicular germ cell tumours. Br J Cancer 107:1754–1760CrossRefPubMedPubMedCentral
7.
go back to reference Liu L, Lian J, Zhang H, et al. (2013) MicroRNA-302a sensitizes testicular embryonal carcinoma cells to cisplatin-induced cell death. J Cell Physiol 228:2294–2304CrossRefPubMed Liu L, Lian J, Zhang H, et al. (2013) MicroRNA-302a sensitizes testicular embryonal carcinoma cells to cisplatin-induced cell death. J Cell Physiol 228:2294–2304CrossRefPubMed
8.
go back to reference Huang H, Tian H, Duan Z, et al. (2014) microRNA-383 impairs phosphorylation of H2AX by targeting PNUTS and inducing cell cycle arrest in testicular embryonal carcinoma cells. Cell Signal 26:903–911CrossRefPubMed Huang H, Tian H, Duan Z, et al. (2014) microRNA-383 impairs phosphorylation of H2AX by targeting PNUTS and inducing cell cycle arrest in testicular embryonal carcinoma cells. Cell Signal 26:903–911CrossRefPubMed
9.
go back to reference Koster R, di Pietro A, Timmer-Bosscha H, et al. (2010) Cytoplasmic p21 expression levels determine cisplatin resistance in human testicular cancer. J Clin Invest 120:3594–3605CrossRefPubMedPubMedCentral Koster R, di Pietro A, Timmer-Bosscha H, et al. (2010) Cytoplasmic p21 expression levels determine cisplatin resistance in human testicular cancer. J Clin Invest 120:3594–3605CrossRefPubMedPubMedCentral
10.
go back to reference Koster R, Timmer-Bosscha H, Bischoff R, et al. (2011) Disruption of the MDM2-p53 interaction strongly potentiates p53-dependent apoptosis in cisplatin-resistant human testicular carcinoma cells viathe Fas/FasL pathway. Cell Death Dis 21:148CrossRef Koster R, Timmer-Bosscha H, Bischoff R, et al. (2011) Disruption of the MDM2-p53 interaction strongly potentiates p53-dependent apoptosis in cisplatin-resistant human testicular carcinoma cells viathe Fas/FasL pathway. Cell Death Dis 21:148CrossRef
Metadata
Title
Why balls are not put inside the basket? A reflection on testicular cancer clinical trial design
Authors
Hampig Raphael Kourie
Fouad Aoun
Publication date
01-08-2016
Publisher
Springer US
Published in
Investigational New Drugs / Issue 4/2016
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-016-0338-7

Other articles of this Issue 4/2016

Investigational New Drugs 4/2016 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine