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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Delcath Systems Inc.
ClinicalTrials.gov Identifier:
NCT01728051
First received: November 13, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Metastatic Liver Cancer
Ocular Melanoma
Cutaneous Melanoma
Drug: Melphalan
Device: Percutaneous Hepatic Perfusion

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open Label, Expanded Access Study of Melphalan Chemosaturation With the Delcath System in Patients With Ocular and Cutaneous Melanoma Metastatic to the Liver

Resource links provided by NLM:


Further study details as provided by Delcath Systems Inc.:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. 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
  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:

  1. Chemotherapy, radiotherapy, or biologic therapy for the malignancy ≤1 month prior to 1st CS-PHP-melphalan infusion
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728051

Locations
United States, California
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Colorado
Sky Ridge Medical Center
Englewood, Colorado, United States, 80112
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, New Jersey
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
United States, Pennsylvania
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Delcath Systems Inc.
Investigators
Principal Investigator: 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 John Wayne Cancer Institute at Saint John's Health Center
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
  More Information

Additional Information:
No publications provided

Responsible Party: Delcath Systems Inc.
ClinicalTrials.gov Identifier: NCT01728051     History of Changes
Other Study ID Numbers: MEL 2009-01
Study First Received: November 13, 2012
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Neoplasms
Melanoma
Skin Neoplasms
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
Skin Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014