Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC
NCT ID: NCT02406508
Last Updated: 2017-12-18
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-10-31
2017-12-31
Brief Summary
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Detailed Description
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Eligible patients will receive up to 3 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD), complete response (CR), and \> 8 weeks delay of recovery from toxicity after last PHP treatment.
With the exception of patients with PD, all patients will be treated with sorafenib after completing the Melphalan/HDS treatment. Patients with PD will be managed with standard of care off-study by their treating physician.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hepatic Delivery System Treatment followed by Sorafenib
Percutaneous hepatic perfusion with melphalan hydrochloride for injection using the Hepatic Delivery System.
Melphalan hydrochloride is administered at a dose of 3mg/kg ideal body weight once every 6 weeks for a maximum of 3 cycles of treatment.
After the Melphalan/HDS treatment patients will be treated with sorafenib according to the package prescribing information.
Melphalan/HDS
Sorafenib
Interventions
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Melphalan/HDS
Sorafenib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Unresectable HCC without extrahepatic disease based on CT
3. At least one target lesion. In patients with prior loco-regional therapy, the target lesion(s) must be located in area(s) outside previous treatment
4. Child-Pugh Class A in the absence of hepatoencephalopathy or clinically evident ascites
5. Barcelona Clinic Liver Cancer (BCLC) stage B
6. MELD Score \< 15
7. Eastern Cooperative Oncology Group Performance Status 0-1
8. No prior systemic therapy for HCC
9. No prior radiation therapy to the liver including Y90-, I131-based loco-regional therapy. Prior loco-regional therapy based on other technology for HCC, if any, must have been completed at least 4 weeks prior to baseline imaging
10. Age ≥ 18 years
11. Signed informed consent
Exclusion Criteria
2. Greater than 50% tumor burden in the liver by imaging
3. History of orthotopic liver transplantation, clinical symptoms of portal hypertension, Whipple's procedure, hepatic artery anatomy incompatible with perfusion or known unresolved venous shunting
4. Evidence of ascites on imaging study, or the use of diuretics for ascites
5. Clinically significant encephalopathy
6. History of allergies or known hypersensitivity to any components of melphalan or the components of the Melphalan/HDS system
7. Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
8. Received an investigational agent for any indication within 30 days prior to first treatment
9. Not recovered from side effects of prior therapy to ≤ grade 1 (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 \[NCI CTCAE v. 4.03\]). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at \> grade 1
10. Those with New York Heart Association functional classification II, III or IV; active cardiac conditions including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia
11. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia
12. Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism
13. Active uncontrolled infection, including Hepatitis B, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but DNA negative are exception(s)
14. History of bleeding disorders
15. Brain lesions with a propensity to bleed
16. Known esophageal varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer
17. Previous malignancy within 3 years prior to enrollment, except for curatively-treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, bladder carcinoma in situ or breast cancer in situ
18. Inadequate hematologic function as evidenced by any of the following:
* Platelets \< 125,000/µL
* Hemoglobin ≤ 10 g/dL, independent of transfusion or growth factor support
* Neutrophils \< 1,500/µL
19. Serum creatinine \> 1.5 mg/dL
20. Inadequate liver function as evidenced by any of the following:
* Total serum bilirubin ≥ 2.0 mg/dL
* Prothrombin time International Normalized Ratio (INR) \> 1.5
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 5 times ULN
* Serum albumin \< 3.0 g/dL
21. Alcohol consumption within 30 days of first study treatment, or refusing to abstain from alcohol for the duration of study treatment
22. For female subjects of childbearing potential (i.e., have had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
23. Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 30 days after last administration of study treatment
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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Leslie Callahan, RN
Role: STUDY_DIRECTOR
Delcath Systems
Locations
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H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Montefiore Medical Center
New York, New York, United States
Countries
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Other Identifiers
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PHP-HCC-201
Identifier Type: -
Identifier Source: org_study_id