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

This study has been completed.
Sponsor:
Collaborators:
Columbia University
ORION Clinical Services
Information provided by:
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT00083941
First received: June 3, 2004
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Biological: TroVax in combination with IL-2
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oxford BioMedica:

Primary Outcome Measures:
  • safety [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: August 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: TroVax in combination with IL-2
    1ml intramuscular injection
  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083941

Locations
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
  More Information

Additional Information:
No publications provided

Responsible Party: S Eastty, Oxford BioMedica
ClinicalTrials.gov Identifier: NCT00083941     History of Changes
Other Study ID Numbers: TV2 Renal
Study First Received: June 3, 2004
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Oxford BioMedica:
Renal Cell Cancer
Requiring IL-2 treatment
Stage IV Renal Cell Cancer

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
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014