A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin (NCT02141906) | Clinical Trial Compass
CompletedPhase 2
A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin
United States20 participantsStarted 2015-01-21
Plain-language summary
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of \>2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level \>400ng/mL and evidence of at least one solid liver lesion \>2cm, regardless of specific imaging characteristics on MRI.
* Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)
* Age ≥ 18 years.
* Performance status ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status).
* Child Pugh Score A only
* Adequate organ and marrow function as defined below:
* leukocytes ≥ 3,000/mcL (Measurement and Calibration Lab)
* absolute neutrophil count ≥ 1,500/mcL
* platelets ≥ 75,000/mcl
* total bilirubin ≤ 3.0
* AST (Aspartate Aminotransferase)(SGOT)/ALT (Alanine Aminotransferase)(SPGT) ≤ 5 X institutional upper limit of normal
* creatinine ≤ 2.0
* INR (International Normalized Ratio) ≤ 1.8
* Albumin ≥ 2.8
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform…
What they're measuring
1
Response
Timeframe: (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.
Trial details
NCT IDNCT02141906
SponsorUniversity of Texas Southwestern Medical Center