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

Conditions:Skin Cancer, Liver Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Contact:Gloria Lee, MD, PhD

Use our guide to learn which trials are right for you!

An Open Label, Expanded Access Study of Melphalan Chemosaturation With the Delcath System in Patients With Ocular and Cutaneous Melanoma Metastatic to the Liver

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.

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

4. Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan

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

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

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


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

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
We found this trial at
100 Madison Avenue
Morristown, New Jersey 07960
Carol G. Simon Cancer Center at Morristown Memorial Hospital Located in northern New Jersey, we...
Morristown, NJ
Click here to add this to my saved trials
4117 East Fowler Avenue
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
Tampa, FL
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
Baltimore, MD
Click here to add this to my saved trials
10101 RidgeGate Pkwy
Lone Tree, Colorado 80124
720) 225-1000
Sky Ridge Medical Center HealthONE is the largest healthcare system in the metro Denver area...
Lone Tree, CO
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
Pittsburgh, PA
Click here to add this to my saved trials
Santa Monica, CA
Click here to add this to my saved trials