A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin
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|ClinicalTrials.gov Identifier: NCT02141906|
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Cancer||Device: Oncozene-DEB-TACE||Not Applicable|
The study will evaluate the safety and tolerability of doxorubicin loaded ONCOZENE microspheres chemoemobilization for the treatment of unresectable hepatocellular carcinoma.
The study will also describe the overall response rates of lesions with Oncozene-DEB-TACE(Trans-arterial chemoemobilization) per modified RECIST criteria (Response Evaluation Criteria in Solid Tumors).
Determine progression free survival (PFS) and overall survival (OS) following Oncozene-DEB-TACE (Trans-arterial chemoemobilization)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin for the Treatment of Patients With Unresectable Hepatocellular Cancer|
|Actual Study Start Date :||January 21, 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Screening Visit (procedures should be done within 28 days of treatment day):
Study visit assessments will be performed prior to Oncozene-DEB-TACE delivery (except pharmacokinetic blood draw).
Labs may be done within 3 days of the procedure. All visits can be completed +/- 10 days of planned visit day
Follow up after completion of treatment every 4-6 weeks:
ONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma.
Other Name: Oncozene microspheres for Doxurubicin delivery
- Response [ Time Frame: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks. ]Treatement response will be measured using modified RECIST assessment for hepatocellular cancer. Patients will undergo a maximum of 3 treatments each, at least 4 weeks apart unless there is a complete response as per mRECIST criteria (no enhancing tumor on subsequent CT or MRI scan)
- Progression [ Time Frame: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks. ]
Treated lesion will be evaluated for progression. Progression will be defined according to the mRECIST criteria (Response Evaluation Criteria in Solid Tumors).Patients will undergo a maximum of 3 treatments each, at least 4 weeks apart unless there is a complete response as per mRECIST criteria (no enhancing tumor on subsequent CT or MRI scan)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141906
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Muhammad Beg, MD||UT Southwestern Medical Center|