Carcinoma, Renal Cell
Conditions
Keywords
Advanced renal cancer, metastatic renal cancer, RCC, kidney cancer, M3thodist
Brief 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.
Detailed description
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.
Interventions
DRUGInterferon-alpha
36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)
BIOLOGICALTroVax® (Immunological Vaccine Therapy)
16 Intramuscular injections of TroVax® over 47 weeks
Sponsors
Oxford BioMedica
The Methodist Hospital Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α. | restaging every 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | restaging every 9 weeks |
| Progression-free survival | restaging every 9 weeks |
| Time to Progression | restaging every 9 weeks |
Countries
United States
Outcome results
None listed