Metastatic Liver CancerNCT01728051
Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
A study testing Melphalan and Percutaneous Hepatic Perfusion in people with Metastatic Liver Cancer and Ocular Melanoma, run by Delcath Systems Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Cancer, Ocular Melanoma, Cutaneous Melanoma
- What is being tested?
- Melphalan and Percutaneous Hepatic Perfusion
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- ≥1 measurable hepatic lesion per RECIST 1.1
- Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
- ECOG PS 0-2
Who cannot join
- 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
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- 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
- History of alcohol or drug abuse ≤6 mths
- 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
- History of hypersensitivity to: melphalan or its components; iodine contrast that cannot be controlled by premedication with antihistamines and steroids; latex
- Known hypersensitivity to heparin in the presence of heparin-induced thrombocytopenia antibodies
- 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
- Inadequate liver function as indicated by any of the following:
- Tbili ≥3.0 mg/dL
- INR >1.5
- AST/ALT >5xULN
- Pregnant or nursing
- Positive pregnancy test in subjects of childbearing potential ≤7 days prior to first CS-PHP-melphalan infusion
- 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
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Sky Ridge Medical Center
Englewood, Colorado, 80112
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
University of Pittsburg Cancer Institute
Pittsburgh, Pennsylvania, 15232
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, 90404
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
About this study
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
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
- Being tested
- Melphalan, Percutaneous Hepatic Perfusion
- Medical subject headings
- Liver Neoplasms, Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Percutaneous Hepatic PerfusionDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Delcath Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles W Nutting, DO, Principal investigator, Sky Ridge Medical CenterJonathan Zager, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institue at University of Southern FloridaMark Faries, MD, Principal investigator, Saint John's Cancer InstituteJames F Pingpank, MD, Principal investigator, Univeristy of Pittsburg Cancer CenterEric D Whitman, MD, Principal investigator, Carol G. Simon Cancer Center at Morristown Memorial HospitalH. Richard Alexander, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728051
- Sponsor's protocol ID
- MEL 2009-01
- Status last verified
- Oct 2013
- First submitted
- 13 Nov 2012
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01728051
- Acronym / sponsor ID
- MEL 2009-01
- Conditions
- Metastatic Liver Cancer, Ocular Melanoma, Cutaneous Melanoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Delcath Systems Inc.Industry (pharma, biotech, devices)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- ≥1 measurable hepatic lesion per RECIST 1.1
- Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
- ECOG PS 0-2
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melphalan | Drug | – |
| Percutaneous Hepatic Perfusion | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles W Nutting, DO principal investigator
Sky Ridge Medical Center
Jonathan Zager, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida
Mark Faries, MD principal investigator
Saint John's Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melphalan and Percutaneous Hepatic Perfusion in people with Metastatic Liver Cancer and Ocular Melanoma, run by Delcath Systems Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.