NCT00445523

Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
BIOLOGICAL	TroVax® (Immunological Vaccine Therapy)	16 Intramuscular injections of TroVax® over 47 weeks
DRUG	Interferon-alpha	36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-01-01
• Completion: 2008-02-01
• First posted: 2007-03-09
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States