Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver

NCT01728051 | Unknown

• 1 other identifier: MEL 2009-01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted in the same patient population as well as using the same melphalan dosing as proposed in this study. This expanded access protocol will provide an experimental alternative treatment option for both physicians and patients until the Delcath CS-PHP System receives marketing approval.

Conditions

Metastatic Liver Cancer; Ocular Melanoma; Cutaneous Melanoma

Interventions

Melphalan DRUG

Percutaneous Hepatic Perfusion DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven ocular/cutaneous melanoma with liver-dominant unresectable metastatic disease, defined as limited extra-hepatic disease and hepatic involvement which would, in the Investigator's opinion, result in morbidity and eventual mortality. Limited extra-hepatic disease considered acceptable includes:
• up to 4 pulmonary nodules, each \<1cm in diameter
• retroperitoneal lymph nodes \<1cm in diameter
• resectable skin or subcutaneous metastases
• asymptomatic bone metastases that have been, or can be, palliated with external beam radiation therapy
• a solitary metastasis to any site that can be resected with limited morbidity or controlled with radiation
• ≥1 measurable hepatic lesion per RECIST 1.1
• Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
• ECOG PS 0-2

You may not qualify if:

• Chemotherapy, radiotherapy, or biologic therapy for the malignancy ≤1 month prior to 1st CS-PHP-melphalan infusion
• Extensive prior radiotherapy, defined as treatment to ≥50% of marrow-containing bones
• Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken currently or ≤3 mths prior to 1st CS-PHP-melphalan infusion
• Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan infusion
• History of orthotopic liver transplantation, untreated gastrinoma (i.e. gastric acid hypersecretion) or prior Whipple procedure
• Not recovered from side effects of prior therapy to ≤ Grade 1 NCI CTCAE 4.03
• Child's B or C cirrhosis, or clinical evidence of portal hypertension
• Patients with \>50% of liver replaced by tumor, histologic evidence of hepatic dysfunction seen by laparoscopic liver biopsy
• History or evidence of clinically significant cardiac disease such as symptomatic arrhythmia, angina/ischemia, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, uncontrolled atrial fibrillation, CHF with a left ventricular ejection fraction \<40%, uncontrolled hypertension (SBP \>190 mmHg or DBP \>100 mmHg), HR outside normal range of 50-100 bpm for women and 45-100 bpm for men
• History/evidence of clinically significant pulmonary or cardiac disease incompatible with fitness to undergo general anesthesia
• Uncontrolled diabetes mellitus or hypo/hyperthyroidism
• Active uncontrolled infection
• History of bleeding disorders or known unresolved venous shunting
• Requirement for ongoing chronic anticoagulation
• Evidence of intracranial abnormalities resulting in risk for bleeding with anticoagulation

Sponsors & Collaborators

• Delcath Systems Inc.: lead

Study Sites (6)

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Sky Ridge Medical Center

Englewood, Colorado, 80112, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

University of Pittsburg Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liver Neoplasms; Uveal Melanoma; Melanoma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Charles W Nutting, DO

  Sky Ridge Medical Center

  PRINCIPAL INVESTIGATOR

• Jonathan Zager, MD

  H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida

  PRINCIPAL INVESTIGATOR

• Mark Faries, MD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

• James F Pingpank, MD

  Univeristy of Pittsburg Cancer Center

  PRINCIPAL INVESTIGATOR

• Eric D Whitman, MD

  Carol G. Simon Cancer Center at Morristown Memorial Hospital

  PRINCIPAL INVESTIGATOR

• H. Richard Alexander, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Last Updated: October 23, 2013

Record last verified: 2013-10

Locations

US (6)