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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

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

Thank you

Trial Information

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 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®

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

- 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

- 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

- No investigational or commercial agents or therapies other that those included in the
protocol treatment may be administered with the intent to treat malignancy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.

Outcome Time Frame:

restaging every 9 weeks

Safety Issue:


Principal Investigator

Robert J Amato, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

February 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Advanced renal cancer
  • metastatic renal cancer
  • RCC
  • kidney cancer
  • M3thodist
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



The Methodist Hospital Research Institute Houston, Texas  77030