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

This study has been completed.
Sponsor:
Collaborator:
Oxford BioMedica
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00445523
First received: March 8, 2007
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α. [ Time Frame: restaging every 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: restaging every 9 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: restaging every 9 weeks ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: restaging every 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2006
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445523

Locations
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Oxford BioMedica
Investigators
Principal Investigator: Robert J Amato, DO The Methodist Hospital Research Institute
  More Information

No publications provided

Responsible Party: Robert J. Amato, DO, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00445523     History of Changes
Other Study ID Numbers: TV2/002/06, 0206-0028
Study First Received: March 8, 2007
Last Updated: August 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
Advanced renal cancer
metastatic renal cancer
RCC
kidney cancer
M3thodist

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

ClinicalTrials.gov processed this record on October 19, 2014