A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Interferon Alfa (IFN-α) on Patients With Advanced or Metastatic Renal Cell Cancer
Patients with metastatic renal cell cancer will be enrolled in the study if all
inclusion/exclusion criteria are met. Once the patient is enrolled, and baseline tests have
been completed, the patient will start treatment.
Trovax® alone arm:
Trovax will be given as an intramuscular injection every two weeks for the first two months,
then once a month for the next 2 months, and then once every 2 months for up to a year.
Trovax® plus IFN-α:
Trovax® schedule will be the same as the Trovax® alone arm. IFN will be given on the first,
third and fifth day of the week for a total of twelve weeks.
At every office visit vital signs will be taken. Every eight weeks a medical history,
physical exam, performance status evaluation, chest x-ray or CT scan, abdomen/pelvis CT scan
or MRI will be done. A blood sample (about 8-10 tablespoons) will be taken to test the
immunological response to TroVax® on the same days that the patient receives TroVax®
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
restaging every 9 weeks
Robert J Amato, DO
The Methodist Hospital Research Institute
United States: Food and Drug Administration
|The Methodist Hospital Research Institute||Houston, Texas 77030|