Study to Evaluate Safety and Biological Activity of TroVax® Vaccine Given in Conjunction With IL-2 to Treat Locally Advanced or Metastatic Renal Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT00325507 |
Recruitment Status
:
Completed
First Posted
: May 12, 2006
Last Update Posted
: August 1, 2008
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Tracking Information | ||||
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First Submitted Date ICMJE | May 10, 2006 | |||
First Posted Date ICMJE | May 12, 2006 | |||
Last Update Posted Date | August 1, 2008 | |||
Study Start Date ICMJE | November 2005 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00325507 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study to Evaluate Safety and Biological Activity of TroVax® Vaccine Given in Conjunction With IL-2 to Treat Locally Advanced or Metastatic Renal Cell Carcinoma | |||
Official Title ICMJE | Safety, Immunology, and Biological Activity Evaluation of TroVax® in Treatment of Patients With Locally Advanced or Metastatic Renal Carcinoma | |||
Brief Summary | The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. TroVax® is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can be received even if one chooses 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 vaccines. 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 cancer cells 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 cells. 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. |
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Detailed Description | Objectives Primary:
Secondary:
Study design: This will be an open label evaluation in patients with clear cell or papillary cell renal carcinoma requiring immunotherapy for locally advanced or metastatic disease. A single dose level of TroVax® in combination with a clinically accepted regimen of subcutaneous low dose IL-2 will be tested in 25 evaluable patients and their immunological responses to TroVax® (antibody and cellular) will be assessed. If immunological activity is observed after two cycles of TroVax®/IL-2 in 70% or more of these patients, further randomised trials will be undertaken to determine the clinical efficacy of TroVax® in this group of patients. The dosage schedule of subcutaneous low dose IL-2 will be an initial dose schedule of 250,000 U/kg/dose for 5 days in week 1 followed by 125,000 U/kg/dose for 5 days in each of weeks 2 though 6 inclusive. There will then be a two-week recovery period before the next cycle commences. The dosage regimen of TroVax® will be injections given prior to the first cycle on two occasions (weeks -2 and 1), and one injection given at the beginning of week 4 of the first cycle. In subsequent cycles, booster injections of TroVax® will be given at week 1 only, prior to commencement of subcutaneous IL-2 therapy. After the first and second cycles of combined treatment, patients will be evaluated by CT scan for their response to treatment. If their disease has progressed after the second cycle, they will be withdrawn from the trial if they require alternative therapy (deterioration of one level of the Karnofsky score or appearance of disease in a new site). If they are experiencing progressive disease that does not require alternative therapy or stable disease or better, they will be treated with cycles of TroVax®/IL-2 as described above for up to a further four cycles. The tumour status will be evaluated by CT scan after every cycle. All patients will be monitored for up to 6 cycles (48 weeks) to assess tolerability, induction of humoural and cellular immunity to 5T4 cell surface antigen, immune response to the vector, tumour response rates, survival, time to progression and progression free survival. Patients who are intolerant of further treatments with subcutaneous IL-2 during this part of the study will be withdrawn from the study. Patients who are still stable or experiencing a tumour response at 48 weeks will be offered further boosts with TroVax® without IL-2 every three months at weeks 52, 64, 76, 88 and 100. During this period, if disease progression recurs, two further cycles with subcutaneous IL-2 as described above may be given in combination with TroVax® as described above with the objective of inducing further disease response or stabilisation. Following termination of all patients' participation in the trial (including those with progressive disease after two cycles of TroVax®/IL-2), contact will be kept by the Investigators with their families in order to determine the date of death. A total of 25 patients will be enrolled. Study population: Inclusion criteria
Exclusion criteria
Withdrawal criteria from the trial:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Renal Cell | |||
Intervention ICMJE | Biological: TroVax® | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
25 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00325507 | |||
Other Study ID Numbers ICMJE | TV-B2/001/05 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Oxford BioMedica | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Oxford BioMedica | |||
Verification Date | July 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |