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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced renal cancer metastatic renal cancer RCC kidney cancer M3thodist |
Interferon-alpha Urinary Tract Neoplasm Interferon Type I, Recombinant Kidney Cancer Immunologic Factors Interferons Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Antiviral Agents |
Carcinoma Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Growth Inhibitors Kidney Diseases Angiogenesis Modulating Agents |
Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Renal Cell Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |