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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg dose loading per vial of doxorubicin | Experimental |
| |
| 75mg dose loading per vial of doxorubicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin, superabsorbent polymer microspheres, embolotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological correlation with surgically resected tumor |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities | ||
| serum doxorubicin release patter | ||
| maximum tolerated dose |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Chung, MD | University of British Columbia | Study Director |
| Jo-Ann Ford, RN | University of British Columbia | Study Director |
| Sharlene Gill, MD | University of British Columbia | Study Director |
| Stephen Ho, MD | University of British Columbia | Study Director |
| David Owen, MD | University of British Columbia | Study Director |
| Charles Scudamore, MD | University of British Columbia | Study Director |
| Ellen Wasan, PhD | University of British Columbia | Study Director |
| Alan Weiss, MD | University of British Columbia | Study Director |
| Eric Yoshida, MD | University of British Columbia | Study Director |
| Sigfried Erb, MD | University of British Columbia |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24982375 | Derived | Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Res. 2014 Jul;34(7):3597-606. |
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|
|
| Study Director |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D004621 | Embolization, Therapeutic |
| D016461 | Chemoembolization, Therapeutic |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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