Status:
COMPLETED
Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma
Lead Sponsor:
Oxford BioMedica
Collaborating Sponsors:
The Methodist Hospital Research Institute
ORION Clinical Services
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Objectives Primary: * To assess the safety and tolerability of TroVax® injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma.
- Primary tumour surgically removed.
- Progressive disease
- At least four weeks from any previous therapy for renal cancer.
- Fit for first or second line immunotherapy with subcutaneous low dose IL-2
- Measurable disease
- Aged 18 years or more.
- Patients must comply with the following:
- Karnofsky score ≥ 80%
- Corrected calcium ≥ 10 g/dL (2.5 mmols/L)
- Clinically immunocompetent
- Free of clinically apparent autoimmune disease.
- Haemoglobin ≥ 9 g/dL, total white cell count ≥ 3 x 10\^9/L and lymphocyte count ≥ 1 x 10\^9/dL
- Serum creatinine up to 1.5 times upper limit of normal.
- Bilirubin ≤ 2 mg% and an SGPT of ≤ 4 times the upper limit of normal.
- Able to give written informed consent and to comply with the protocol.
- 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®.
- No acute changes on 12-lead electrocardiogram (ECG)
- Ejection fraction on echocardiogram ≥ 45%
Exclusion
- Previous immunotherapy with any schedule of IL-2.
- Intercurrent serious infections within the 28 days prior to entry into the trial.
- Life threatening illness unrelated to cancer.
- Cerebral metastases on MRI scan.
- History of allergic response to previous vaccinia vaccinations.
- Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days or during the course of this trial.
- 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.
- 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.
- Known allergy to egg proteins
- Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
- Known to test positive for HIV or hepatitis B or C
- Known hypersensitivity to neomycin
- Pregnancy or lactation
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00325507
Start Date
November 1 2005
End Date
July 1 2008
Last Update
October 19 2020
Active Locations (1)
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1
The Methodist Hospital
Houston, Texas, United States, 77030