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

March 15, 2016 updated by: The Methodist Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Intron

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: restaging every 9 weeks
restaging every 9 weeks
Progression-free survival
Time Frame: restaging every 9 weeks
restaging every 9 weeks
Time to Progression
Time Frame: restaging every 9 weeks
restaging every 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Collaborators

Oxford BioMedica

Investigators

  • Principal Investigator: Robert J Amato, DO, Baylor College of Medicine - Methodist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 8, 2007

First Submitted That Met QC Criteria

March 8, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMRI IRB#0206-0028
  • TV2/002/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Renal Cell

Clinical Trials on TroVax® (Immunological Vaccine Therapy)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe