Clinical Bibliography

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Oncology Drug Advisory Committee Briefing Materials
Melblez Kit™, May 2, 2013

• Delcath Briefing Information
  FDA Briefing Information

• Delcath ODAC Presentations
  FDA ODAC Presentations

Articles

• Alexander, R. et al. Current Status of Percutaneous Hepatic Perfusion as Regional Treatment for Patients with Unresectable Hepatic Metastases: A Review, American Oncology and Hematology Review 2014: 15-23

• Schulze-Bergkamen et al. Unresectable isolated hepatic metastases from solid pseudopapillary neoplasm of the pancreas: A case report of chemosaturation with high-dose melphalan. Pancreatology (published online Sep 2014)

• Vogl, et al. Chemosaturation with Percutaneous Hepatic Perfusions of Melphalan for Hepatic Metastases: Experience from Two European Centers, Fortschr Röntgestr published online 2014

• Forster M., et al. Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable Metastatic Melanoma or Sarcoma to the Liver: A Single Institution Experience. Journal of Surgical Oncology. 2013 Oct 27. [Epub ahead of print]

• Yamamoto M, Zager J. Isolated Hepatic Perfusion for Metastatic Melanoma. Journal of Surgical Oncology. 2013 Sept 26. [Epub ahead of print]

• Agarwala SS, et al. Metastatic melanoma to the liver: A contemporary and comprehensive review of surgical, systemic, and regional therapeutic options. Cancer. 2013 Dec 2. doi: 10.1002/cncr.28480.

• Deneve JL, et al. Chemosaturation with Percutaneous Hepatic Perfusion for Unresectable Isolated Hepatic Metastases from Sarcoma.Cardiovasc Intervent Radiol. 2012 Jun 15. [Epub ahead of print]

• Gilcher RO. Additional separate report on analysis of porcine PHP procedures using Delcath gen 2 filters. Report. 2011 Sept. 30.

• Han D, et al. Minimally invasive intra-arterial therapy for metastatic melanoma: Isolated limb infusion and percutaneous hepatic perfusion. Expert Opinion on Drug Metabolism and Toxicology. 2011; 7(10):1-12.

• Alexander HR Jr, Butler CC. Development of isolated hepatic perfusion via the operative and percutaneous techniques for patients with isolated and unresectable liver metastases. Cancer J. 2010 Mar-Apr;16(2):132-41. doi: 10.1097/PPO.0b013e3181db9c0a. Review.

• Pingpank JF. Melphalan for colorectal metastases to the liver. Clin Adv Hematol Oncol. 2010 Mar;8(3):175-7.

• Miao N, et al. Percutaneous hepatic perfusion in patients with metastatic liver cancer: anesthetic, hemodynamic, and metabolic considerations. Ann Surg Oncol. 2008 Mar;15(3):815-23.

• Muehlbauer PM, et al. Part II: nursing implications of administering chemotherapy in interventional radiology or the operating room. Clin J Oncol Nurs. 2006;10:345-356

• Pingpank JF, et al. Phase I study of hepatic arterial melphalan infusion and hepatic venous hemofiltration using percutaneously placed catheters in patients with unresectable hepatic malignancies. J Clin Oncol. 2005;23:3465-3474

Index of Abstracts

• Prof. Dr. Boris A. Radeleff, et al. Isolierte Chemosaturation bei hepatischen Metastasen eines Frantz-Tumors. IROS - Interventional Radiology Olbert Symposium 2014. Salzburg, 16-18.1.2014.
    Poster

• Alexander HR. Hepatic perfusion (CHEMOSAT^® or CS-PHP) of melphalan vs. best alternative care in patients with hepatic metastases from melanoma: Update of a randomized phase 3 study. 2012-09, ESMO 2012, Vienna, Austria.
  Abstract   Poster

• Gardner ER, et al. Percutaneous hepatic perfusion (CHEMOSAT^® or CS-PHP) of melphalan in patients with hepatic metastases from melanoma: Phase III pharmacokinetic analysis. 2012-09, ESMO 2012, Vienna, Austria
  Abstract   Poster

• Testori A, et al. Chemosaturation therapy with percutaneous hepatic perfusion (CS-PHP) for unresectable hepatic metastases: the European Institute of Oncology (EIO) Experience. 2012-09, ESSO 2012, Valencia, Spain
  Abstract

• Gardner ER, et al. Pharmacokinetic Analysis of Percutaneous Hepatic Perfusion of Melphalan in Patients with Hepatic Metastases from Melanoma. 2012-09, ILCA 2012, Berlin, Germany
  Abstract   Presentation Slides

• Moeslein F, et al. Chemosaturation with percutaneous hepatic perfusions: vasopressor, nitroglycerin, and pre-embolization requirements. 2012-09, ILCA 2012, Berlin, Germany
  Abstract   Presentation Slides

• Moeslein F, Nutting CW. Chemosaturation with percutaneous hepatic perfusions (CS-PHP): Utilization of vasopressors, nitroglycerin, and pre-embolization. 2012-11, BSIR 2012, Bournemouth, UK
  Abstract

• Alexander HR. Percutaneous hepatic perfusion (PHP or CHEMOSAT^®) with melphalan versus best alternative care in patients with hepatic metastases from melanoma: A post-hoc analysis of PHP-randomized vs BAC-to-PHP crossover vs BAC-only pts. 2012-06, ASCO 2012, Chicago, USA.
  Abstract   Poster

• Gardner ER, et al. Pharmacokinetic analysis of Percutaneous Hepatic Perfusion (PHP) of melphalan in patients with hepatic metastases from melanoma. 2012-06, WCGIC 2012, Barcelona, Spain.
  Abstract   Presentation Slides   Poster

• Kandarpa K. Chemosaturation therapy with percutaneous hepatic perfusion in patients with hepatic metastases from melanoma: exploratory data from a randomized controlled phase 3 study. 2012-05, APCCVIR 2012, Kobe, Japan; abstract 131 2012-05.
  Abstract   Presentation Slides

• Kandarpa K. Chemosaturation therapy with percutaneous hepatic perfusions of melphalan versus best alternative care in patients with hepatic metastases: randomized multicenter phase 3 study. 2012-05, APCCVIR 2012, Kobe, Japan; abstract 136.
  Abstract   Presentation Slides

• Moeslein F, Nutting CW. Chemosaturation using percutaneous hepatic perfusion: pre-embolization of GI branches in a phase 3 clinical trial. 2012-05, GEST 2012, New York City, USA.
  Abstract   Presentation Slides

• Zager J, Nutting CW. Chemosaturation therapy with percutaneous hepatic perfusions of melphalan versus standard of care in patients with hepatic metastases from melanoma: A randomized multicenter phase 3 study. 2012-03, SIR 2012.
  Abstract   Presentation Slides

• Pingpank JF, et al. Chemo-saturation with Percutaneous Hepatic Perfusion (CS:PHP) using Melphalan for Unresectable Neuroendocrine Tumor Liver Metastases (MNET). 2011-09, CIRSE 2011.
  Abstract

• Pingpank JF, et al. Percutaneous hepatic perfusion (PHP) with melphalan for patients with unresectable liver metastases of neuroendocrine tumors (MNET): NCT00096083. 2011-09, ECCO-ESMO 2011; Abstract 6621.
  Abstract   Poster

• Pingpank JF, et al. Percutaneous hepatic perfusion vs. best alternative care for patients with melanoma liver metastases - efficacy update of the phase 3 trial (NCT00324727). 2011-09, ECCO-ESMO 2011; Abstract 9304.
  Abstract   Presentation Slides

• Antoine RA. Technical considerations in percutaneous hepatic perfusion--a multi-center experience. J Extra Corpor Technol. 2011 Mar;43(1):30-3.
  Abstract

• Pingpank JF. Long term results utilizing high dose intra-arterial melphalan delivered via percutaneous hepatic perfusion (PHP) for patients with unresectable hepatic metastases from primary neuroendocrine tumors. 2011-03, AHPBA 2011.
  Abstract

• Pingpank JF, et al. A phase III random assignment trial comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to standard of care for patients with hepatic metastases from metastatic ocular or cutaneous melanoma. 2010-06, ASCO 2010; Abstract LBA8512.
  Abstract   Presentation Slides

• Turaga K. Multi-regional chemoperfusion for metastatic melanoma. 5th International Symposium on Regional Cancer Therapies Meeting. San Juan, Puerto Rico, February 2010.
  Abstract

• Bartlett E, et al. Continuous hemofiltration of hepatic venous effluent allows regional delivery of high-dose melphalan via a minimally invasive approach. 2008-03, AHPBA 2008; Abstract 158.
  Abstract

• Pingpank JF, et al. High dose intra-arterial melphalan delivered via percutaneous hepatic perfusion (PHP) for patients with unresectable hepatic metastases from primary neuroendocrine tumors. 2008-03, AHPBA 2008; Abstract 211.
  Abstract   Presentation Slides

• Pingpank JF, et al. Impact of high-dose melphalan (MEL) administered via hepatic arterial infusion for patients with unresectable hepatic metastases (LM) from ocular melanoma (OM). 2008-01, ASCO GI 2008; Abstract 170.
  Abstract

• Pingpank JF, et al. Analysis of clinical toxicity in patients undergoing percutaneous intra-arterial hepatic perfusion (PHP) with melphalan for unresectable hepatic malignancies. 2007-05, WCIO 2007; Abstract 18.
  Abstract   Presentation Slides

• Burns WR, et al. Percutaneous liver perfusion for patients with metastatic neuroendocrine tumors. 2007-02, ISRCT 2007.
  Abstract   Poster

• Farma JM, et al. Percutaneous hepatic perfusion with melphalan for patients with metastatic melanoma to the liver. 2005-03, SSO 2005; Abstract 10068.
  Abstract   Poster

• Neeman Z, et al. Percutaneous hepatic perfusion for primary and secondary liver tumors—interventional radiology initial experience. 2004-03, SIR 2004.
  Abstract

• Pingpank JF, et al. A phase I dose-escalation study of hepatic arterial melphalan infusion with hepatic venous hemofiltration using percutaneously placed catheters in patients with unresectable hepatic malignancies. 2004-01, ASCO GI 2004; Abstract 99.
  Abstract

• Pingpank JF, et al. A phase I feasibility study of hepatic arterial melphalan infusion with hepatic venous hemofiltration using percutaneously placed catheters in patients with unresectable hepatic malignancies. 2003-06, ASCO 2003; Abstract 1131, Proc Am Soc Clin Oncol 22: 2003 (abstr 1131).
  Abstract   Poster