Carcinoma, Renal Cell Clinical Trial
Official title:
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
Verified date | March 2016 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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-a, 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine - Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Methodist Hospital System | Oxford BioMedica |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-a. | restaging every 9 weeks | No | |
Secondary | Overall survival | restaging every 9 weeks | No | |
Secondary | Progression-free survival | restaging every 9 weeks | No | |
Secondary | Time to Progression | restaging every 9 weeks | No |
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