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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445523
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : March 17, 2016
Oxford BioMedica
Information provided by (Responsible Party):
The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Biological: TroVax® (Immunological Vaccine Therapy) Drug: Interferon-alpha Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
TroVax® alone
Biological: TroVax® (Immunological Vaccine Therapy)
16 Intramuscular injections of TroVax® over 47 weeks

Experimental: 2
TroVax® plus IFN-α
Biological: TroVax® (Immunological Vaccine Therapy)
16 Intramuscular injections of TroVax® over 47 weeks

Drug: Interferon-alpha
36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)
Other Name: Intron

Primary Outcome Measures :
  1. Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α. [ Time Frame: restaging every 9 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: restaging every 9 weeks ]
  2. Progression-free survival [ Time Frame: restaging every 9 weeks ]
  3. Time to Progression [ Time Frame: restaging every 9 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445523

United States, Texas
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Oxford BioMedica
Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital

Responsible Party: The Methodist Hospital System Identifier: NCT00445523     History of Changes
Other Study ID Numbers: HMRI IRB#0206-0028
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
Advanced renal cancer
metastatic renal cancer
kidney cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs