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A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083941
Recruitment Status : Completed
First Posted : June 7, 2004
Last Update Posted : October 19, 2020
Columbia University
ORION Clinical Services
Information provided by (Responsible Party):
Oxford BioMedica

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Biological: TroVax
1ml intramuscular injection

Biological: Interleukin-2
Intravenous IL-2
Other Name: IL-2

Primary Outcome Measures :
  1. To assess safety and tolerability of TroVax [ Time Frame: duration of study ]
    incidence of adverse events, laboratory tests and occurrence of dose limiting toxicity

  2. To assess immune responses induced by treatment with TroVax [ Time Frame: duration of study ]
    positive antibody response for the vector (MVA) / tumour (5T4)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic renal clear cell adenocarcinoma, histologically proven by biopsy of the primary tumour and/or a metastasis. If a fresh specimen is obtained for diagnostic purposes, it may be frozen and stained for 5T4. Prior nephrectomy is not required.
  • Requiring treatment with IL-2 and able to tolerate a high dose schedule per institutional standards.
  • Aged 18 years or more.
  • Performance status (ECOG) 0 or 1.
  • Expected survival longer than three months.
  • No clinically active autoimmune disease.
  • Total white cell count greater than or equal to 3 x 109/l.
  • Platelet count greater than or equal to 90,000/mm3.
  • Serum creatinine 1.6 mg/dl or less.
  • Total bilirubin 1.6 mg/dl or less.
  • Serum AST/ALT greater than or equal to three times the upper limit of normal or 5 times upper limit of normal if liver metastases are present.
  • Able to give written informed consent and to comply with the protocol.
  • Women must be either post menopausal, rendered surgically sterile or practising a reliable form of contraception (hormonal, intrauterine device or barrier). Men must practise an effective form of birth control, such as barrier protection.
  • Normal cardiac stress test if the patients are older than 50 years of age or have symptoms of cardiac disease.
  • Normal pulmonary function tests if the patient is a smoker or is known to have primary lung disease.

Exclusion Criteria:

  • Pregnancy, lactation or lack of effective contraception in fertile men and women of childbearing potential.
  • Intercurrent serious infections within the 28 days prior to entry to the trial.
  • Known to be HIV positive because HIV infection can lead to serious adverse events with vaccination and/or high-dose IL-2.
  • Life threatening illness unrelated to cancer.
  • Cerebral metastases.
  • History of allergic response to previous vaccinia vaccinations.
  • Participation in any other clinical trial within the previous 30 days .
  • Previous malignancies within the last two years other than successfully treated squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
  • 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.
  • Corticosteroids unless used as an antiemetic.
  • Family contact with active eczema, exfoliative skin disorder, pregnancy or other cause of immunocompromise.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00083941

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United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Oxford BioMedica
Columbia University
ORION Clinical Services
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Principal Investigator: Howard L Kaufman, MD Columbia University
Additional Information:
Publications of Results:
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Responsible Party: Oxford BioMedica Identifier: NCT00083941    
Other Study ID Numbers: TV2 Renal
First Posted: June 7, 2004    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Oxford BioMedica:
Renal Cell Cancer
Requiring IL-2 treatment
Stage IV Renal Cell Cancer
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs