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An International, Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate Whether TroVax, Added to First-line Standard of Care Therapy, Prolongs the Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.


Phase 3
18 Years
N/A
Not Enrolling
Both
Clear Cell Renal Carcinoma

Thank you

Trial Information

An International, Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate Whether TroVax, Added to First-line Standard of Care Therapy, Prolongs the Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.


This is an international, randomised, double blind, placebo controlled, parallel group study
to investigate whether a minimum of three doses of TroVax® added to first-line standard of
care therapy, prolongs the survival of patients with locally advanced or metastatic renal
clear cell adenocarcinoma.

The primary endpoint is survival. The study is designed to be pragmatic, limiting additional
study related investigations to a minimum. Protocol mandated scans and X-rays are limited to
two time points (baseline and week 26) to permit comparison of the percentage of patients
with progressive disease at 6 months as a secondary efficacy endpoint. Six months was
selected based on review of published literature indicating that progressive disease was
commonly observed by 26 weeks in patients with renal cancer. Endpoints such as tumour
response by RECIST are considered of secondary importance to survival and will be determined
by radiological examinations ordered at the discretion of the investigator based on the
clinical status of the patient and will be based the interpretation of the patient's
care-team (investigator and local radiologist).

After signing the study informed consent form and meeting the baseline enrolment criteria
patients will be assigned by the investigator (their physician) to one of the following
defined first-line standard of care regimens based on what is best for the patient and
consistent with local practice:

1. subcutaneous low dose IL-2

2. interferon-α (excluding pegylated IFNα)

3. sunitinib

TroVax® is administered at a dose of 1E9TCID50/ml in 1ml by injection into the deltoid
muscle of the upper arm at regular intervals up to 8 weeks apart up to a maximum of 13
doses.


Inclusion Criteria:



- Signed informed consent. The patient must be competent to give written informed
consent and comply with the protocol requirements.

- Locally advanced or metastatic, histologically proven clear cell renal carcinoma.

- Primary tumour surgically removed (some residual advanced primary tumour may remain).

- At least four weeks post surgery or radiotherapy.

- First-line. No prior therapy for renal cancer except surgery or radiotherapy.

- Measurable disease.

- Aged 18 years or more.

- Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the
investigator there is a >90% probability that the patient will survive >12 weeks if
treated with the selected standard of care).

- Free of clinically apparent autoimmune disease (including no prior confirmed
diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis,
Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant
diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).

- Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L.

- Serum creatinine ≤1.5 times the upper limit of normal.

- Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper
limit of normal.

- Women must be either post menopausal, or rendered surgically sterile or, if of child
bearing potential, must have been practising a reliable form of contraception (oral
contraception + a barrier method) for at least three months prior to the first dose
of TroVax® and must continue while they are being treated with TroVax®. Men must
practise a reliable form of contraception (barrier or vasectomy) while they are being
treated with TroVax®.

- No acute changes on 12-lead ECG.

- Ejection fraction documented as not less than 45% or no clinical suspicion that
cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection
fraction should be measured according to local site procedures).

- Karnofsky performance status of ≥ 80%.

Exclusion Criteria:

- Cerebral metastases. (Known from previous investigations or clinically detectable).

- Previous exposure to TroVax®.

- Serious infections within the 28 days prior to entry to the trial.

- Known to test positive for HIV or hepatitis B or C.

- Life threatening illness unrelated to cancer.

- History of allergic response to previous vaccinia vaccinations.

- Known allergy to egg proteins.

- Known hypersensitivity to neomycin.

- Participation in any other clinical trial of a licensed or unlicensed drug within the
previous 30 days or during the course of this trial.

- Previous malignancies within the last 10 years other than successfully treated
squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone
biopsy.

- Previous history of major psychiatric disorder requiring hospitalization or any
current psychiatric disorder that would impede the patient's ability to provide
informed consent or to comply with the protocol.

- Oral corticosteroid use unless prescribed as replacement therapy in the case of
adrenal insufficiency.

- Ongoing use of agents listed in locally approved prescribing information as causing
immunosuppression.

- Prior history of organ transplantation.

- Pregnancy or lactation.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

18 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

TV3/001/06

NCT ID:

NCT00397345

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Clear Cell Renal Carcinoma
  • Renal
  • TroVax
  • survival
  • metastatic
  • Kidney
  • cancer
  • immunotherapy
  • Locally advanced or metastatic, measurable, histologically proven clear cell renal carcinoma.
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

University of Texas Medical BranchGalveston, Texas  77555-1329
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Virginia Oncology AssociatesNewport News, Virginia  23606
Seattle Cancer Care AllianceSeattle, Washington  98109
Scripps Cancer CenterLa Jolla, California  92037
Augusta Oncology AssociatesAugusta, Georgia  30901
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Columbia Presbyterian Medical CenterNew York, New York  10032
The Methodist HospitalHouston, Texas  77030
Sharp Health CareSan Diego, California  92123
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
AZ Cancer CenterTucson, Arizona  85724
Little Rock Hematology / Oncology Associates, P.A.Little Rock, Arkansas  72205
The Angeles Clinic and Reseach InstituteLA, California  90025
La Jolla, CALa Jolla, California  92093
1300 N. Vermont AveLos Angeles, California  90027
UCLA Urology/OncologyLos Angeles, California  90095
UCHSCAurora, Colorado  80045
Washington Cancer CenterWashington, District of Columbia  20010
SCORE Physician AllianceSaint Petersburg, Florida  33709
SMO-USA Inc.Canton, Georgia  301115
North Idaho Cancer CentreCoeur D'Alene, Idaho  83814
Patricia A. Joyce Cancer InstituteOlympia Fields, Illinois  60461
Edward H Kaplan and AssociatesSkokie, Illinois  60076
St Francis HospitalIndianapolis, Indiana  46107
Cancer Care Centre of IndianaNew Albany, Indiana  47150
Henry Ford Health System / Josephine Ford Cancer CenterDetroit, Michigan  48202
University Minnesota Fairview Medical CenterMinneapolis, Minnesota  55455
Haematology and Oncology Associates at BridgeportTupelo, Mississippi  38801
Charleston Hematology and Oncology Associates,Billings, Montana  59101
Billings Clinical Research CenterBillings, Montana  59107
Freedman UrologyLas Vegas, Nevada  89109
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
The Cancer Center @ HUMCHackensack, New Jersey  07601
Pluta Cancer CentreRochester, New York  14623
Piedmont Hospital, Inc.Canton, Ohio  30309
Riverside Cancer CentreColumbus, Ohio  43214
Heamatology and Oncology Associates Inc.Columbus, Ohio  43235
Flower Hospital/ Promedica Health SystemSylvania, Ohio  43560
Oregon Urology InstituteSpringfield, Oregon  97477
Cancer Centre of the CarolinasGreenville, South Carolina  29605
Urology Associates of South TexasMcAllen, Texas  78503
Cancer Outreach Associates PCAbingdon, Virginia  24211
Madigan Army Medical CentreTacoma,, Washington  98109