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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

This study has been completed.
Sponsor:
Collaborators:
The Methodist Hospital System
ORION Clinical Services
Information provided by:
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT00325507
First received: May 10, 2006
Last updated: July 31, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
 Biological: TroVax®
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Immunology, and Biological Activity Evaluation of TroVax® in Treatment of Patients With Locally Advanced or Metastatic Renal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oxford BioMedica:

Estimated Enrollment: 25
Study Start Date: November 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma.
  2. Primary tumour surgically removed.
  3. Progressive disease
  4. At least four weeks from any previous therapy for renal cancer.
  5. Fit for first or second line immunotherapy with subcutaneous low dose IL-2
  6. Measurable disease
  7. Aged 18 years or more.

  8. Patients must comply with the following:

    • Karnofsky score ≥ 80%
    • Corrected calcium ≥ 10 g/dL (2.5 mmols/L)
  9. Clinically immunocompetent
  10. Free of clinically apparent autoimmune disease.
  11. Haemoglobin ≥ 9 g/dL, total white cell count ≥ 3 x 10^9/L and lymphocyte count ≥ 1 x 10^9/dL
  12. Serum creatinine up to 1.5 times upper limit of normal.
  13. Bilirubin ≤ 2 mg% and an SGPT of ≤ 4 times the upper limit of normal.
  14. Able to give written informed consent and to comply with the protocol.
  15. Women must be either post menopausal, or rendered surgically sterile or, if of child bearing potential, must have been practising a reliable form of contraception (oral contraception + a barrier method) for at least three months prior to the first dose of TroVax® and must continue while they are being treated with TroVax®. Men must practise a reliable form of contraception while they are being treated with TroVax®.
  16. No acute changes on 12-lead electrocardiogram (ECG)
  17. Ejection fraction on echocardiogram ≥ 45%

Exclusion Criteria:

  1. Previous immunotherapy with any schedule of IL-2.
  2. Intercurrent serious infections within the 28 days prior to entry into the trial.
  3. Life threatening illness unrelated to cancer.
  4. Cerebral metastases on MRI scan.
  5. History of allergic response to previous vaccinia vaccinations.
  6. Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
  7. Previous malignancies within the last 10 years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
  8. Previous history of major psychiatric disorder requiring hospitalisation or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
  9. Known allergy to egg proteins
  10. Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
  11. Known to test positive for HIV or hepatitis B or C
  12. Known hypersensitivity to neomycin
  13. Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325507

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Oxford BioMedica
The Methodist Hospital System
ORION Clinical Services
Investigators
Principal Investigator: Robert J Amato, MD The Methodist Hospital System
  More Information

Additional Information:
(Oxford BioMedica company information)  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00325507     History of Changes
Other Study ID Numbers: TV-B2/001/05
Study First Received: May 10, 2006
Last Updated: July 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Oxford BioMedica:
Renal cell cancer
requiring IL-2 treatment
Locally advanced or metastatic renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013