Advanced or Metastatic Renal Cell Cancer
Conditions
Interventions
Product Name: TroVax
Product Code: TV
Pharmaceutical Form: Suspension for injection
Current Sponsor code: TroVax
Concentration type: ran
Sponsors
Oxford MioMedica UK Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma. If previously treated at least four weeks from any previous therapy (except Interferon a) for renal cancer includi,ng surgery chemotherapy, immunotherapy, or radiotherapy. (Patients receiving interferon a whose renal cancer is stable may also be included in the study) Newly diagnosed or progressive of stable measurable disease as defined by the RECIST criteria Patients receiving first or second line treatment for locally advanced or metastatic renal cancer. Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study. Patients must be well enough to tolerate first or second line immunotherapy with interferon alpha. Measurable disease. Aged 18 years or more. Patients must comply with 2 out of 3 of the following: a. Karnofsky score greater than or equal to 80%. b. Haemoglobin concentration greater than or equal to 13g/dL (males) or 11.5 g/dL (females) c. Corrected calcium less than or equal to 10 g/dL (2.5 mmols/L). Clinically immunocompetent. Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease). Total white cell count greater than or equal to 3 x 10e9/L and lymphocyte count greater than or equal to 1 x 10e9/dL. Serum creatinine up to 1.5 times upper limit of normal. ALT, AST and bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Serious infections within the 28 days prior to entry to the trial. Prior TroVax Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study. Already completed prior second line therapy for advanced or metastatic renal cancer. (Note however that patients currently receiving interferon as second line therapy for advanced or metastatic renal cancer who are stable (ie do not demonstrate response or progression by RECIST criteria) may enter the study) Major surgery or radiation therapy completed less than or equal to 4 weeks prior to enrollment. Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days. (except sorafanib or sutnitinib who may enter the study after 7 days discontinuation) Cerebral metastesis on MRI scan "Currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse. Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled. Psychiatric illnesses/social situations that would limit compliance with protocol requirements. Creatinine 21.5 x ULN. Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency. Clinical indication of reduced cardiac function or an ejection fraction of r 40%. Requirement for radiotherapy (this is a sign of disease progression and is classed as a withdrawal criterion). Concurrent chemotherapy, immunotherapy and radiation therapy No investigational or commercial agents or therapies other than those included in protocol treatment may be administered with the intent to create regression of the patient's malignancy. 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 psychosis or of major a psychiatric disorder requiring hospitalization 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. Known to test positive for HIV or hepatitis B or C. Pregnancy or lactation. Prior history of organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether IFN-a markedly increases the cellular or humoral anti-5T4 response to TroVax compared to that observed in previous studies using TroVax alone, in combination with IL-2 or with chemotherapy. ; Secondary Objective: Though this is a phase I/II feasibility study to assess the safety and immunological activity of TroVax combined with IFN-a, tumour response in each patient will also be evaluated using RECIST criteria. ; Primary end point(s): Immunology endpoints Antibody response to 5T4 as measured by ELISA Cellular response to 5T4 antigen as measured by lFN gamma Elispot Primary safety endpoints Assessment of the number of adverse events and serious adverse events Assessment of safety by analysis of clinical laboratory variables (complete blood count and chemistry panel). Efficacy endpoint Tumour outcomes will be reported according to RECIST criteria. | — |
Countries
United Kingdom
Outcome results
None listed