A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT00083941|
Recruitment Status : Completed
First Posted : June 7, 2004
Last Update Posted : October 19, 2020
The purpose of this study is to test the safety of an investigational vaccine called TroVax when given in conjunction with Interleukin-2 (IL-2) treatment. TroVax is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is standard treatment for your cancer, which means that you could receive it even if you choose not to participate in this study. TroVax is being studied as a possible treatment for patients with cancer of the kidney.
TroVax belongs to a class of medicines called a vaccine. A vaccine helps the body's immune system to recognize and kill foreign invading organisms effectively. It is believed that one of the reasons why cancer can spread through the body is that the immune system cannot recognize them as being different from normal tissues and therefore cannot kill the cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the body could lead to the immune system being able to target and kill those cancer cells effectively. This trial is of a completely new way of trying to treat cancer in the future by the use of vaccination injections. TroVax consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer calls. When the virus is injected, it makes the protein, and the body's immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells).
The purpose of this study is to assess the safety and tolerability of TroVax injections and to understand whether TroVax could make such an immune response happen in patients with renal cell cancer while receiving Interleukin-2 (IL-2). This study will also observe and monitor any side effects experienced in patients who receive TroVax while being treated with IL-2.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Biological: TroVax Biological: Interleukin-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction With Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: TroVax and IL-2
TroVax: Intramuscular into the deltoid muscle of the upper arm, 10x dose (6.83 x 108 pfu/ml). IL 2: High dose IL 2, 600,000 IU/kg intravenously every 8 hours up to a maximum of 15 injections.
1ml intramuscular injection
Other Name: IL-2
- To assess safety and tolerability of TroVax [ Time Frame: duration of study ]incidence of adverse events, laboratory tests and occurrence of dose limiting toxicity
- To assess immune responses induced by treatment with TroVax [ Time Frame: duration of study ]positive antibody response for the vector (MVA) / tumour (5T4)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083941
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Howard L Kaufman, MD||Columbia University|