A Two-Stage Phase II Safety and Efficacy Study of IntraDose (Cisplatin/Epinephrine) Injectable Gel (MPI 5010) Administered to Patients With Unresectable Primary Hepatocellular Carcinoma
OBJECTIVES: I. Evaluate the safety and efficacy of cisplatin-epinephrine injectable gel
(Intradose MPI-5010) in patients with unresectable primary hepatocellular carcinoma.
OUTLINE: This is an open label, two stage, multicenter study. Patients receive intratumoral
treatment with ciplatin-epinephrine (MPI-5010) once weekly, for up to four treatments within
a six week period, followed by an evaluation two weeks after last treatment. Immediately
after the first course, an optional second course of treatment may be undertaken at the
discretion of the investigator. Patients with a complete response, partial response, and/or
an increase in necrosis of at least 30% of total treated tumor volume will be followed
monthly for up to 6 months. At the completion of 6 months follow up or following
documentation of disease progression or development of new tumors, patients are monitored
for survival in an extended follow up period. All nonresponders at the last 2 week
posttreatment evaluation are entered in the extended follow up and monitored monthly for
survival.
PROJECTED ACCRUAL: Up to 55 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Richard D. Leavitt, MD
Study Chair
Matrix Pharmaceutical
United States: Federal Government
CDR0000065675
NCT00003044
September 1996
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |