Status:
COMPLETED
Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Oxford BioMedica
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00445523
Start Date
May 1 2006
End Date
February 1 2008
Last Update
March 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030