Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
NCT ID: NCT01728051
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Melphalan
Percutaneous Hepatic Perfusion
Eligibility Criteria
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Inclusion Criteria
* 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
2. ≥1 measurable hepatic lesion per RECIST 1.1
3. Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
4. ECOG PS 0-2
Exclusion Criteria
2. Extensive prior radiotherapy, defined as treatment to ≥50% of marrow-containing bones
3. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken currently or ≤3 mths prior to 1st CS-PHP-melphalan infusion
4. Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan infusion
5. History of orthotopic liver transplantation, untreated gastrinoma (i.e. gastric acid hypersecretion) or prior Whipple procedure
6. Not recovered from side effects of prior therapy to ≤ Grade 1 NCI CTCAE 4.03
7. Child's B or C cirrhosis, or clinical evidence of portal hypertension
8. Patients with \>50% of liver replaced by tumor, histologic evidence of hepatic dysfunction seen by laparoscopic liver biopsy
9. 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
10. History/evidence of clinically significant pulmonary or cardiac disease incompatible with fitness to undergo general anesthesia
11. Uncontrolled diabetes mellitus or hypo/hyperthyroidism
12. Active uncontrolled infection
13. History of bleeding disorders or known unresolved venous shunting
14. Requirement for ongoing chronic anticoagulation
15. Evidence of intracranial abnormalities resulting in risk for bleeding with anticoagulation
16. History of alcohol or drug abuse ≤6 mths
17. Other malignancy within 3 yrs before enrollment with the exception of curatively treated basal or squamous cell carcinoma of the skin, or curatively treated cervical, breast carcinoma in situ or prostate cancer
18. History of hypersensitivity to: melphalan or its components; iodine contrast that cannot be controlled by premedication with antihistamines and steroids; latex
19. Known hypersensitivity to heparin in the presence of heparin-induced thrombocytopenia antibodies
20. Inadequate hematological or renal function as indicated by any of the following:
* Platelets \<100,000/mm3
* Hb ≤10 g/dL
* Neutrophils \<2,000/mm3
* S Creat \>1.5 mg/dL or measured creatinine clearance \<60 mL/min/1.73 m2
21. Inadequate liver function as indicated by any of the following:
* Tbili ≥3.0 mg/dL
* INR \>1.5
* AST/ALT \>5xULN
22. Pregnant or nursing
23. Positive pregnancy test in subjects of childbearing potential ≤7 days prior to first CS-PHP-melphalan infusion
24. Women who are pre-menopausal (i.e. have had a menstrual period ≤12 months) who are unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
25. Sexually active females of childbearing potential and sexually active males with partners of reproductive potential unwilling or unable to use contraception from screening until at least 30 days after last administration of CS-PHP-melphalan
18 Years
ALL
No
Sponsors
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Delcath Systems Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Charles W Nutting, DO
Role: PRINCIPAL_INVESTIGATOR
Sky Ridge Medical Center
Jonathan Zager, MD
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida
Mark Faries, MD
Role: PRINCIPAL_INVESTIGATOR
Saint John's Cancer Institute
James F Pingpank, MD
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Pittsburg Cancer Center
Eric D Whitman, MD
Role: PRINCIPAL_INVESTIGATOR
Carol G. Simon Cancer Center at Morristown Memorial Hospital
H. Richard Alexander, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States
Sky Ridge Medical Center
Englewood, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MEL 2009-01
Identifier Type: -
Identifier Source: org_study_id