NCT00325507

Brief Summary

The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. TroVax® is the experimental product in this trial and its value as a medicine has not yet been proven. Interleukin-2 (IL-2) is a standard treatment for cancer, which means that it can be received even if one chooses not to participate in this study. TroVax® is being studied as a possible treatment for patients with cancer of the kidney. TroVax® belongs to a class of medicines called vaccines. A vaccine helps the body's immune system to recognize and kill foreign invading organisms effectively. It is believed that one of the reasons why cancer can spread through the body is that the immune system cannot recognize cancer cells as being different from normal tissues and therefore cannot kill the cancer cells. A vaccine that alerts the immune system to the presence of cancer cells in the body could lead to the immune system being able to target and kill those cancer cells effectively. This trial is of a completely new way of trying to treat cancer in the future by the use of vaccination injections. TroVax® consists of a virus that has been changed so that it is no longer infectious and carries a gene for a protein called 5T4. This protein is carried by many kidney cancer cells. When the virus is injected, it makes the protein, and the body's immune system is then able to recognize this protein and kill the cells that have it (i.e. the cancer cells). The purpose of this study is to assess the safety and tolerability of TroVax® injections and to understand whether TroVax® could make such an immune response happen in patients with renal cell cancer while receiving interleukin-2 (IL-2). This study will also observe and monitor any side effects experienced in patients who receive TroVax® while being treated with IL-2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

May 10, 2006

Last Update Submit

October 9, 2020

Conditions

Carcinoma, Renal Cell

Keywords

renal cell carcinomarequiring IL-2 treatmentLocally advanced or metastatic renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of TroVax injections in conjunction with low dose IL-2

    To assess the safety and tolerability of TroVax injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally advanced or metastatic clear cell or papillary cell renal carcinoma. To assess the immune responses induced by treatment with TroVax and subcutaneous IL-2

    48 weeks

Secondary Outcomes (1)

  • Tumour Response Rates

    6, 12 & 24 months

Study Arms (1)

TroVax

EXPERIMENTAL

TroVax given as first or second line treatment in conjuntion with low dose IL-2.

Biological: TroVaxDrug: IL-2

Interventions

TroVaxBIOLOGICAL

TroVax 1 x 10E9 TCID 50mL

TroVax
IL-2DRUG

IL-2 250,000 U/kg S/C for cycle 1 and day 1 of subsequent cycles, 125,000U/kg S/C for days 2-5 of cycles 2-6

TroVax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced or metastatic, histologically proven clear cell or papillary cell renal carcinoma.
  • Primary tumour surgically removed.
  • Progressive disease
  • At least four weeks from any previous therapy for renal cancer.
  • Fit for first or second line immunotherapy with subcutaneous low dose IL-2
  • Measurable disease
  • Aged 18 years or more.
  • Patients must comply with the following:
  • Karnofsky score ≥ 80%
  • Corrected calcium ≥ 10 g/dL (2.5 mmols/L)
  • Clinically immunocompetent
  • Free of clinically apparent autoimmune disease.
  • Haemoglobin ≥ 9 g/dL, total white cell count ≥ 3 x 10\^9/L and lymphocyte count ≥ 1 x 10\^9/dL
  • Serum creatinine up to 1.5 times upper limit of normal.
  • Bilirubin ≤ 2 mg% and an SGPT of ≤ 4 times the upper limit of normal.
  • +4 more criteria

You may not qualify if:

  • Previous immunotherapy with any schedule of IL-2.
  • Intercurrent serious infections within the 28 days prior to entry into the trial.
  • Life threatening illness unrelated to cancer.
  • Cerebral metastases on MRI scan.
  • History of allergic response to previous vaccinia vaccinations.
  • 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 hospitalisation or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
  • Known allergy to egg proteins
  • Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
  • Known to test positive for HIV or hepatitis B or C
  • Known hypersensitivity to neomycin
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Amato RJ, Shingler W, Naylor S, Jac J, Willis J, Saxena S, Hernandez-McClain J, Harrop R. Vaccination of renal cell cancer patients with modified vaccinia ankara delivering tumor antigen 5T4 (TroVax) administered with interleukin 2: a phase II trial. Clin Cancer Res. 2008 Nov 15;14(22):7504-10. doi: 10.1158/1078-0432.CCR-08-0668.

    PMID: 19010868RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

TroVaxInterleukin-2

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Robert J Amato, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

November 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(1)