Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Interferon Alfa (IFN-α) on Patients With Advanced or Metastatic Renal Cell Cancer

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Biological: TroVax® (Immunological Vaccine Therapy)
* Drug: Interferon-alpha


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TroVax® alone | Biological: TroVax® (Immunological Vaccine Therapy)<br>* 16 Intramuscular injections of TroVax® over 47 weeks<br>|
| Experimental: 2<br>TroVax® plus IFN-α | Biological: TroVax® (Immunological Vaccine Therapy)<br>* 16 Intramuscular injections of TroVax® over 47 weeks<br>Drug: Interferon-alpha<br>* 36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)<br>* Other names: Intron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α. |  | restaging every 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | restaging every 9 weeks | 
| Progression-free survival |  | restaging every 9 weeks | 
| Time to Progression |  | restaging every 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCC, Advanced renal cancer, metastatic renal cancer, kidney cancer, M3thodist