Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
Overview[ - collapse ][ - ]
| Purpose | The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal. |
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| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy |
| Phase | Phase 1/Phase 2 |
| Sponsor | University of British Columbia |
| Responsible Party | University of British Columbia |
| ClinicalTrials.gov Identifier | NCT01116635 |
| First Received | May 3, 2010 |
| Last Updated | March 14, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 3, 2010 |
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| Last Updated Date | March 14, 2014 |
| Start Date | January 2010 |
| Estimated Primary Completion Date | January 2012 |
| Current Primary Outcome Measures | Histopathological correlation with surgically resected tumor [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC) |
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| Official Title | Phase I/II Study Examining Pharmacokinetics, Adverse Events, and Surgically Resected Histopathological Response Utilizing a Dose Escalation Model of Doxorubicin Loaded Drug Eluting Superabsorbent Polymer Microspheres in Surgically Resectable Hepatocellular Carcinoma in Humans |
| Brief Summary | The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere. Other Names:
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| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 24 |
| Estimated Completion Date | January 2012 |
| Estimated Primary Completion Date | January 2012 |
| Eligibility Criteria | Inclusion Criteria: - Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC) |
| Gender | Both |
| Ages | 19 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01116635 |
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| Other Study ID Numbers | H08-02833 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of British Columbia |
| Study Sponsor | University of British Columbia |
| Collaborators | Not Provided |
| Investigators | Study Director: Stephen Chung, MD University of British ColumbiaStudy Director: Jo-Ann Ford, RN University of British ColumbiaStudy Director: Sharlene Gill, MD University of British ColumbiaStudy Director: Stephen Ho, MD University of British ColumbiaStudy Director: David Owen, MD University of British ColumbiaStudy Director: Charles Scudamore, MD University of British ColumbiaStudy Director: Ellen Wasan, PhD University of British ColumbiaStudy Director: Alan Weiss, MD University of British ColumbiaStudy Director: Eric Yoshida, MD University of British ColumbiaStudy Director: Sigfried Erb, MD University of British Columbia |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Vancouver General Hospital | Vancouver, British Columbia, Canada |
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