Uwe Trefzer

Charité - Universitätsmedizin Berlin

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Dirk Schadendorf

Essen University Hospital

Ralf Gutzmer

Ruhr University Bochum

Carmen Loquai

University Medical Center of the Johannes Gutenberg University Mainz

Wolfram Sterry

Charité - Universitätsmedizin Berlin

Axel Hauschild

University Hospital Schleswig-Holstein

Selma Ugurel

Deutschen Konsortium für Translationale Krebsforschung

Jessica C. Hassel

University Hospital Heidelberg

Claus Garbe

University of Tübingen

Peter Mohr

Elbe Kliniken Stade-Buxtehude

Carola Berking

Friedrich-Alexander-Universität Erlangen-Nürnberg

Cooperative Institutions

Charité - Universitätsmedizin Berlin

129

Heidelberg University

Humboldt-Universität zu Berlin

University Hospital Heidelberg

German Cancer Research Center

Ludwig-Maximilians-Universität München

Freie Universität Berlin

Hautklinik Heidelberg

Melanoma Institute Australia

Medizinische Hochschule Hannover

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BREAK-MB: A phase II study assessing overall intracranial response rate (OIRR) to dabrafenib (GSK2118436) in patients (pts) with BRAF V600E/k mutation-positive melanoma with brain metastases (mets).

Journal of Clinical Oncology (2012)

John M. Kirkwood Georgina V. Long Uwe Trefzer Michael A. Davies Paolo A. Ascierto

8501 Background: Melanoma brain mets carry a poor prognosis (median survival ≤4 months), for which more effective therapies are needed. Dabrafenib is a potent, selective oral inhibitor of mutated BRAF that has demonstrated clinical efficacy in pts with BRAF V600E/K mutant melanoma and previously untreated brain mets in a phase I study. Therefore, a phase II study (BREAK-MB) was initiated. Methods: Stage IV pts with ≥ 1 intracranial met (0.5 cm–4 cm assessed by MRI) without prior brain therapy (Cohort A) or with progression following prior brain therapy (Cohort B) were eligible with V600E/K mutation. Pts received dabrafenib 150 mg BID. The primary endpoint was investigator-assessed OIRR among V600E mutation-positive pts. Results: Overall, 172 pts were recruited. At interim analysis, of 127 pts enrolled (safety population), 41 (Cohort A n=24; Cohort B n=17) had reached 8-week disease assessment. Unconfirmed OIRR in Cohort A was 10/19, (53%; 95% CI: 28.9–75.6%) for V600E and 1/5 (20%; 95% CI: 0.5–71.6%) for V600K pts. In Cohort B unconfirmed OIRR was 8/15 (53%; 95% CI: 26.6%–78.7%) for V600E and 1/2 (50%; 95% CI: 1.3–98.7%) for V600K pts. Unconfirmed overall response rate (ORR) in Cohort A was 10/19 (53%; 95% CI: 28.9–75.6%) for V600E and 1/5 (20%; 95% CI: 0.5–71.6%) for V600K pts. In Cohort B unconfirmed ORR was 6/15 (40%; 95% CI: 16.3–67.7%) for V600E and 1/2 (50%; 95% CI: 1.3–98.7%) for V600K pts. In the safety population, 12/63 pts (19%) in Cohort A reported an SAE; 1 (2%) was fatal (cerebral hemorrhage). In Cohort B 15/64 pts (25%) reported an SAE; 1 (2%) was fatal (seizure). In Cohort A, 47 pts (75%) experienced AEs: 9 grade 3 (14%) and 3 grade 4 (5%). The most common AEs were headache (21%), hyperkeratosis and rash (17% each). In Cohort B, 47 pts (73%) experienced AEs: 12 grade 3 (19%) and 3 grade 4 (5%). The most common AEs were fatigue or nausea (22% each) and pyrexia (17%). Conclusions: Dabrafenib shows high clinical activity both in pts with intra- and extracranial mets with acceptable toxicity. Final data will be presented.

Dabrafenib

Clinical endpoint

10.1200/jco.2012.30.15_suppl.8501

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Citations (29)

Multimodal fusion imaging ensemble for targeted sentinel lymph node management: initial results of an innovative promising approach for anatomically difficult lymphatic drainage in different tumour entities

European Journal of Nuclear Medicine and Molecular Imaging (2006)

Sofiane Maza Matthias Taupitz Kasra Taymoorian Klaus Winzer Jens C. Rückert

Gamma probe

10.1007/s00259-006-0223-2

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Citations (18)

Supplementary Table Legends from The Genetic Landscape of Clinical Resistance to RAF Inhibition in Metastatic Melanoma

Eliezer M. Van Allen Nikhil Wagle Antje Sucker Daniel J. Treacy Cory M. Johannessen

PDF file 73K, This file contains legends for the five supplementary tables

Table (database)

10.1158/2159-8290.22530894

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Cytokines: interleukin and interferon therapy in dermatology

Clinical and Experimental Dermatology (2002)

K. Asadullah Wolfram Sterry Uwe Trefzer

Journal Article Cytokines: interleukin and interferon therapy in dermatology Get access K. Asadullah, K. Asadullah Schering AG, Berlin, Germany, and K. Asadullah, Schering AG, D‐13342 Berlin, Germany. E‐mail: khusru.asadullah@schering.de Search for other works by this author on: Oxford Academic Google Scholar W. Sterry, W. Sterry Department of Dermatology and Allergy, University Hospital Charité, Berlin Humboldt University, Germany Search for other works by this author on: Oxford Academic Google Scholar U. Trefzer U. Trefzer Department of Dermatology and Allergy, University Hospital Charité, Berlin Humboldt University, Germany Search for other works by this author on: Oxford Academic Google Scholar Clinical and Experimental Dermatology, Volume 27, Issue 7, 1 October 2002, Pages 578–584, https://doi.org/10.1046/j.1365-2230.2002.01144.x Published: 01 October 2002 Article history Accepted: 17 June 2002 Published: 01 October 2002

10.1046/j.1365-2230.2002.01144.x

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Citations (40)

Vakzinationstherapie des malignen Melanoms

Springer eBooks (1998)

Uwe Trefzer Peter Walden Wolfram Sterry

10.1007/978-3-642-71974-5_77

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A Phase I Trial with a Hybrid Cell Vaccine in Patients with Metastatic Melanoma

Advances in experimental medicine and biology (1998)

Uwe Trefzer Guido Weingart Y. Chen Karin Adrian Heike Audring

Streptamer

10.1007/978-1-4615-5357-1_80

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Hybrid cell vaccination for cancer immune therapy: First clinical trial with metastatic melanoma

International Journal of Cancer (2000)

Uwe Trefzer Guido Weingart Yingwen Chen Gunda Herberth Karin Adrian

Hybrid cell vaccination is a new cancer immune therapy approach that aims at recruiting T cell help for the induction of tumour specific cytolytic immunity. The vaccines are generated by fusion of the patients' tumour cells with allogeneic MHC class II bearing cells to combine the tumour's antigenicity with the immunogenicity of allogeneic MHC molecules. Safety and anti-tumour activity of this treatment were assessed in a clinical trial that has yielded one complete and one partial remission, and 5 cases of stable disease among 16 patients with advanced stage metastatic melanoma. As evidenced by histology, the vaccination induced T cell relocation into tumour nodules. Stable disease could be maintained by repeated booster injections for more than 24 months in some patients. The side effects were minor. Occasional occurrences of vitiligo spots after vaccination were indicative of a restricted therapy induced auto-immune reactivity. The results suggest that hybrid cell vaccination is a safe cancer immune therapy potentially effective for induction of acute anti-tumour response as well as long-term maintenance. Int. J. Cancer 85:618–626, 2000. © 2000 Wiley-Liss, Inc.

10.1002/(sici)1097-0215(20000301)85:5<618::aid-ijc4>3.0.co;2-z

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Citations (103)

Botulinumtoxin zur Behandlung von therapierefraktären Erythemen und Hautrötung bei Rosacea

Kompass Dermatologie (2015)

Bastian Schilling Jürgen Lademann Grainne M. O’Kane Tomás G. Lyons Gabrielle Colleran

Hintergrund: Persistierende Erytheme und eine schwere Hautrötung im Rahmen von Rosacea können mit erheblichen physischen Beschwerden und psychischer Belastung des Patienten verbunden sein. Derzeit gibt es keine zufriedenstellenden Therapieoptionen. Methoden: Wir berichten über 2 Fälle von therapierefraktären rosaceabedingten Hautrötungen und Erythemen, die mit intradermalen Botulinumtoxin-Injektionen erfolgreich behandelt werden konnten. Ergebnisse: Bei beiden Patientinnen wurden ästhetisch gute Ergebnisse erzielt. Die Nebenwirkungen während und nach der Behandlung waren leichte Schmerzen und lokal begrenzte Hämatome; diese Beschwerden klangen ohne weitere Behandlung innerhalb einiger Tage ab. Schlussfolgerung: Intradermale Botulinumtoxin-Injektionen sind möglicherweise eine wirksame Behandlungsoption bei therapierefraktären rosaceabedingten Erythemen und Hautrötungen; ihre weiterführende Untersuchung in einer größeren Patientenpopulation ist gerechtfertigt. Übersetzung aus Park KY, et al: Botulinum toxin for the treatment of refractory erythema and flushing of rosacea. Dermatology 2015;230:299-301 (DOI: 10.1159/000368773)

10.1159/000435793

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Multicenter phase II trial of the histone deacetylase inhibitor pyridylmethyl-N-{4-[(2-aminophenyl)-carbamoyl]-benzyl}-carbamate in pretreated metastatic melanoma

Melanoma Research (2008)

Axel Hauschild Uwe Trefzer Claus Garbe Katharina C. Kaehler Selma Ugurel

Systemic treatment of metastatic melanoma is of low efficacy, and new therapeutic strategies are needed. Histone deacetylase inhibitors are supposed to restore the expression of tumor suppressor genes and induce tumor cell differentiation, growth arrest, and apoptosis. This study was aimed to evaluate the efficacy, safety, and pharmacokinetics of the histone deacetylase inhibitor pyridylmethyl-N-{4-[(2-aminophenyl)-carbamoyl]-benzyl}-carbamate (MS-275) in patients with pretreated metastatic melanoma. Patients with unresectable AJCC stage IV melanoma refractory to at least one earlier systemic therapy were randomized to receive MS-275 3 mg biweekly (days 1+15, arm A) or 7 mg weekly (days 1+8+15, arm B), in 4-week cycles. The primary study endpoint was objective tumor response, secondary endpoints were safety and time-to-progression. On the basis of Simon's two-stage design, the study initially allowed an entry of 14 patients per arm; if there was at least one responder, additional 33 patients were to be enrolled. Among 28 patients enrolled, no objective response was detected. Four (29%) patients in arm A and three (21%) patients in arm B showed disease stabilizations. Median time-to-progression was comparable in both arms with 55.5 versus 51.5 days, respectively; median overall survival was 8.84 months. Toxicity was mild to moderate with nausea (39%) and hypophosphatemia (29%) as the most frequently reported events. No treatment-related serious adverse events occurred. Single-agent treatment with MS-275 was well-tolerated and showed long-term tumor stabilizations, but no objective responses in pretreated metastatic melanoma. Further evaluation of MS-275 in combination schedules is warranted.

Clinical endpoint

Histone deacetylase inhibitor

10.1097/cmr.0b013e328307c248

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Hybrid Cell Vaccination for Cancer Immune Therapy

Peter Walden Gernot Stuhler Uwe Trefzer

This chapter contains sections titled: Introduction Immunological Basis of the HCV Approach to Cancer Immune Therapy Tumor Antigenicity T-T Cell Collaboration in the Induction of Cellular Cytotoxic Immune Responses Vaccination Strategies for Cancer Immune Therapy HCV Conceptual Basis HCV in Preclinical Studies Clinical Experience with HCV Conclusion and Prospects

Antigenicity

Cancer Therapy

10.1002/3527600795.ch11

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Citations (1)