Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® will delay tumor progression.
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® injections.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
16 Intramuscular injections of TroVax® over 47 weeks
36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
Time frame: restaging every 9 weeks
Overall survival
Time frame: restaging every 9 weeks
Progression-free survival
Time frame: restaging every 9 weeks
Time to Progression
Time frame: restaging every 9 weeks
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