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Sponsors and Collaborators: |
The Methodist Hospital System Oxford BioMedica |
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Information provided by: | The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT00445523 |
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.
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Biological: TroVax® (Immunological Vaccine Therapy) Drug: Interferon-alpha |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 28 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
TroVax® alone
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Biological: TroVax® (Immunological Vaccine Therapy)
16 Intramuscular injections of TroVax® over 47 weeks
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2: Experimental
TroVax® plus IFN-α
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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)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The Methodist Hospital Research Institute | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert J Amato, DO | The Methodist Hospital Research Institute |
Responsible Party: | The Methodist Hospital Research Institute ( Robert J. Amato, DO ) |
Study ID Numbers: | TV2/002/06, 0206-0028 |
Study First Received: | March 8, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00445523 |
Health Authority: | United States: Food and Drug Administration |
Advanced renal cancer metastatic renal cancer RCC kidney cancer M3thodist |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |