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

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Biological: TroVax® (Immunological Vaccine Therapy); Drug: Interferon-alpha

• Registration Number: NCT00445523
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Interferon-alpha	TroVax® plus IFN-α
1	TroVax® (Immunological Vaccine Therapy)	TroVax® alone
2	TroVax® (Immunological Vaccine Therapy)	TroVax® plus IFN-α

Primary Outcome Measures

Name	Time	Method
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.	restaging every 9 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival	restaging every 9 weeks
Time to Progression	restaging every 9 weeks
Progression-free survival	restaging every 9 weeks

Trial Locations

Locations (1)

Baylor College of Medicine - Methodist Hospital; 🇺🇸 Houston, Texas, United States