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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Collaborator: Oxford BioMedica
• Treatments: Interferon-alpha; Interferons; Vaccines

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.