safety study of trovax alone vs. trovax plus interferon alpha in patients with renal cancer

Conditions: Carcinoma, Renal Cell

Summary: patients with metastatic renal cell cancer will be enrolled to receive either trovax® alone or trovax® plus interferon alfa. the study will try to determine whether the use of trovax® will delay tumor progression.

patients with metastatic renal cell cancer will be enrolled in the study if all inclusion/exclusion criteria are met. once the patient is enrolled, and baseline tests have been completed, the patient will start treatment. trovax® alone arm: trovax will be given as an intramuscular injection every two weeks for the first two months, then once a month for the next 2 months, and then once every 2 months for up to a year. trovax® plus ifn-α: trovax® schedule will be the same as the trovax® alone arm. ifn will be given on the first, third and fifth day of the week for a total of twelve weeks. at every office visit vital signs will be taken. every eight weeks a medical history, physical exam, performance status evaluation, chest x-ray or ct scan, abdomen/pelvis ct scan or mri will be done. a blood sample (about 8-10 tablespoons) will be taken to test the immunological response to trovax® on the same days that the patient receives trovax® injections.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic histologically confirmed clear cell or papillary cell renal carcinoma. * primary tumor surgically removed. * stable or progressive disease as defined by recist criteria. * age ≥ 18 years. * at least one prior standard of care therapy (il-2, ifn-α, or approved kinase inhibitor) * at least four weeks from prior use of standard of care therapy. * karnofsky performance status ≥ 80%. * corrected serum calcium ≥ 10 g/dl. * patients on stable doses of bisphosphonates (fosamax, actonel, didrocal) that show subsequent tumor progression may continue on this medication; however patients are not allowed to start bisphosphonates within one month prior to starting trial, or throughout the duration of the trial. * major surgery or radiation therapy completed ≥ 4 weeks prior to treatment. * clinically immunocompetent. * free of clinically apparent autoimmune disease. * absolute lymphocyte count ≥ 500/μl, absolute neutrophil count ≥ 1200/μl, platelet count ≥ 100,000/μl, hemoglobin ≥ 9mg/dl. * no evidence of active ischemia on electrocardiogram (ecg) * women must be either post-menopausal, rendered surgically sterile, or using reliable form of contraceptive. * able to give informed consent and comply with the protocol. exclusion criteria: * prior treatment with trovax® * no supplements of complementary medicines/botanicals are permitted during study, except for any combination of the following: multivitamins, selenium, lycopene, soy supplements, vitamin e. * prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. * participation in any other clinical trial within 30 days. * cerebral metastasis 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 which are uncontrolled. * psychiatric illnesses that would limit compliance with protocol. * a history of psychosis or clinical depression. * liver function tests (alt, ast) more than 1.5 x upper limit of normal (uln). bilirubin must be within normal limits. * creatinine ≥ 1.5 x uln. * known allergy to egg proteins. * known allergy to neomycin. * history of allergic response to previous vaccinia vaccinations. * chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency. * positive for hiv or hepatitis b or c. * clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%. * pregnancy or lactation * current chemotherapy, immunotherapy, radiation therapy, or the requirement for radiotherapy. * no investigational or commercial agents or therapies other that those included in the protocol treatment may be administered with the intent to treat malignancy.

Keywords: advanced renal cancer metastatic renal cancer rcc kidney cancer m3thodist