Status:
COMPLETED
A Study of TroVax Vaccine Given in Conjunction With IL-2 for Treatment of Stage IV Renal Cell Cancer
Lead Sponsor:
Oxford BioMedica
Collaborating Sponsors:
Columbia University
ORION Clinical Services
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tr...
Detailed Description
Objectives Primary * To assess the safety and tolerability of TroVax injections when given as a therapeutic vaccine to patients with metastatic renal cell cancer * To assess the immune responses ind...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00083941
Start Date
August 1 2004
End Date
July 1 2008
Last Update
October 19 2020
Active Locations (1)
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1
Columbia Presbyterian Medical Center
New York, New York, United States, 10032