View Trial - USC/Norris Cancer Center Clinical Trials

Details for trial 3L-03-1

Description:	A Phase II Study of Intra-Arterial Chemotherapy with Cisplatin and Mitomycin-C in Patients with Hepatocellular Carcinoma.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Syma Iqbal	M.D.

Data Management

Name	Title
Ramona Lujan	R.N.
jiayi jiang	D.M.
Noureddine Miloud	D.M.

You may participate in this study if:

	Requirement
1	Unresectable, histologically confirmed hepatocellular carcinoma with evident disease limited to liver. All patients will have malignancy confirmed by review of biopsy specimens by the Division of Pathology of USC – LAC/Norris Cancer Center/University Hospital. Tissue from tumor must be available. This may be paraffin-embedded tissue from previous biopsy/resection or if not available, a repeat biopsy must be performed. The requirement for biopsy may be waived if alpha-fetoprotein is >500 ng/ml and in MD’s opinion, is not explained by a concurrent hepatic inflammatory process.
2	Must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
3	Measurable disease. If with prior RT, measurable disease must be outside radiation field.
4	At least 18 years of age.
5	Zubrod performance status 0-2.
6	AGC = / >1.5; platelets = / >50,000; Hgb = / >9.0 (AGC requirement may be waived if in MD’s opinion the lower count reflects hypersplenism with adequate BM reserves).
7	Bilirubin < / = 2 x uln (regardless of whether patient has liver involvement secondary to tumor). Patients may not have ascites or ascites must be responsive to diuretics.
8	Calculated CrCl at least 60 ml/min.
9	Predicted life expectancy of at least 12 weeks.
10	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	Prior chemotherapy for unresectable disease.
2	Any active or uncontrolled infection, including known HIV infection. Patients with active hepatitis B will be placed on lamivudine. Patients with active hepatitis C will be eligible if liver tests qualify.
3	Psychiatric disorders that would interfere with consent or follow-up.
4	History of prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which patient has been disease-free for at least 5 years.
5	Pregnant or lactating females. Men and women of reproductive potential must agree to use an effective contraceptive method.
6	Any other severe concurrent disease, which in the judgment of investigator, would make patient inappropriate for study entry.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.