A Pilot Study of * OncozeneTM * Microspheres for intra-arterial delivery of doxorubicin for the treatment of patients with unresectable hepatocellular cancer

Study ID
STU 012014-079

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Runail Ratnani
214/648-5478
Runail.Ratnani@UTSouthwestern.edu

Principal Investigator
Muhammad Beg, M.D.

Summary

Treatment Dosage and administration

oncozene-DeB-TaCe is offered to patients with unilobar or Bilobar tumors (hepatocellular carcinoma).

unilobar tumors:
- Patients will undergo 1 treatment

Bilobar tumors:
- Patients will undergo a maximum of 2 treatments
- The therapy is directed to either lobe at each session of chemoembolization.
- Repeat therapy to a specific lobe is not performed if there is a complete response to as per mReCiST criteria.

endpoints:
Response: Treatment response will be measured
Death: Death due to any cause.
Progression: Treated lesion will be evaluated for progression. Progression will be defined.
Toxicity: Toxicity will be measured using CTae v4.0
QoL: HRQoL will be measured using the PRoMiS Global Scale.

Participant Eligibility

3.1 Inclusion Criteria

3.1.1 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.

3.1.2 Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)

3.1.3 Age >18 years

3.1.4 Performance status ECOG PS 0-1.

3.1.5 Child Pugh Score A or B

3.1.6 Adequate organ and marrow function as defined below:

Leukocytes >= 3,000/mcL
Absolute Neutrophil Count (ANC) >= 1,500/mcL
Platelets >= 50,000/mcl
Total Bilirubin <= 3.0
AST(SGOT) / ALT(SPGT) <= 5 x ULN
Creatinine <= 2.0
INR <= 1.8


3.1.7 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 her treating physician immediately.

3.1.7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:


* Has not undergone a hysterectomy or bilateral oophorectomy; or

* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

3.1.8 Absence of occlusive thrombus in the main portal vein

3.1.9 Ability to understand and the willingness to sign a written informed consent..