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Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-Small-Cell Lung Cancer After Tumour Removal by Surgery
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290355
  Purpose

Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Biological: GSK 249553 vaccine
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Liothyronine sodium Triiodothyronine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of days from surgical resection to the recurrence of NSCLC (all types of recurrence will be included). [ Time Frame: At the time of analysis ]

Secondary Outcome Measures:
  • Recurrence [ Time Frame: 6, 12, 18, 24 and 30 months after enrolment ]
  • Disease-free survival [ Time Frame: At the time of analysis ]
  • Time to death [ Time Frame: At the time of analysis ]
  • Time to lung cancer death [ Time Frame: At the time of analysis ]
  • Lung-cancer-related death. [ Time Frame: 30 months after enrolment ]
  • Antibodies to MAGE-3 and protein D [ Time Frame: At all points during treatment as specified in the study schedule ]
  • In vitro cellular immune response [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Serum level of Cyfra21.1 and CEA [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Level of plasma DNA and molecular characterisation by loss of heterozygosity and microsatellite instability [ Time Frame: At all points during treatment as specified in the study schedule. ]
  • Number of circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
  • MAGE-3 expression in circulating tumour cells in the blood [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Gene expression profiles of primary and relapsed tumour samples [ Time Frame: At the time of resection ]
  • Proteomes of the patients' plasma [ Time Frame: At all points during treatment as specified in the study schedule ]
  • Solicited local and general signs and symptoms recorded by the patients on diary cards [ Time Frame: For a period of 7 days following each administration of vaccine/placebo ]
  • Unsolicited non-serious adverse events [ Time Frame: Reported at any time until 30 days following the most recent administration of vaccine/placebo ]
  • All serious adverse events [ Time Frame: At any time during the study ]
  • Haematological, biochemical and urinalysis parameters [ Time Frame: At regular intervals during the study ]

Estimated Enrollment: 180
Study Start Date: May 2002
Estimated Study Completion Date: June 2009
Detailed Description:

This Phase IIb study will be conducted at centres in several European countries according to a multicentre, international, randomised, double-blind design. It will provide information about the clinical and immunological efficacy and the tolerability of GSK 249553 when this is administered to patients with stage IB, II NSCLC. The study treatment will be administered by intramuscular injection; first administration will take place 4-6 weeks after surgery. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

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

Inclusion criteria:

  • Written informed consent have been obtained prior to surgical tumour resection and prior to the performance of any other protocol-specific procedures.
  • At least 18 years of age at the time of resection.
  • Pathologically proven, surgically staged squamous or non-squamous IB, IIA or IIB NSCLC, and complete surgical resection.
  • The operative technique for resection of the patient's tumour involves at least a lobectomy or a sleeve lobectomy, conforming to all of the following criteria:

    1. Removal of all gross disease with negative resection margins, by lobectomy, sleeve resection, bilobectomy or pneumonectomy, based on intra-operative findings.
    2. The level of nodal sampling is at least as follows:

Levels 4, 7, 10 in both right upper and right middle lobes Levels 4, 7, 9, 10 in right lower lobe Levels 5, 6, 7 in left upper lobe Levels 7, 9, 10 in left lower lobe. or at the maximum defined as systematic radical mediastinal lymphadenectomy: all ipsilateral and easily accessible lymph-node levels must be removed, independently of the location of the primary tumour. The level of nodal sampling is as follows: Levels 2, 4, 7, 8, 9, 10 in right-sided tumours, Levels 5, 6, 7, 8, 9, 10 in left-sided tumours

  • Tumour shows expression of MAGE-3 antigen.
  • Recovered from surgery for at least 4 weeks and not more than 6 weeks.
  • ECOG performance status of ≤ 1 at the time of randomisation.
  • Laboratory criteria (all of the following must be fulfilled): adequate bone marrow reserve, adequate renal function, adequate hepatic function, serum bilirubin within normal range, negative HIV antibody test, negative HBV antigen test, negative HCV antibody test.
  • (For females): EITHER not of child-bearing potential OR sexually abstinent OR all of the following: negative urine/serum β-HCG pregnancy test, use of adequate contraceptive precautions for 30 days before first vaccination. Agree to continue such precautions for 2 months after completion of the course of vaccination.

Exclusion criteria:

  • Received any anti-cancer specific treatment including radiotherapy, prior to surgery, unless the treatment was for previous malignancies allowed by the protocol, i.e., basal and localised squamous-cell skin carcinoma that has been successfully treated, or carcinoma in situ of the cervix (see exclusion criterion no. 10).
  • Candidate for post-surgery radiation therapy or any kind of anti-cancer-specific treatment.
  • Pregnant/lactating.
  • (For female patients of child-bearing potential): not agree to practice an effective method of contraception.
  • Uncontrolled bleeding disorder.
  • Autoimmune disease.
  • History of anaphylaxis or severe allergic reaction.
  • Undergone splenectomy or radiation to the spleen.
  • Received a major organ allograft.
  • Malignancies at other sites (except (i) basal and localised squamous-cell skin carcinoma that has been successfully treated, and (ii) carcinoma in situ of the cervix).
  • Concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • Uncontrolled congestive heart failure or hypertension.
  • Unstable heart disease or uncontrolled arrhythmia at the time of enrolment.
  • Psychiatric or addictive disorders that may compromise ability to give informed consent, or to comply with the trial procedures.
  • Any evidence of residual tumour after surgery.
  • Require concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  • Received chemotherapy, immunotherapy related to NSCLC.
  • Need home oxygenation.
  • Received any investigational or non-registered drug or vaccine other than the study vaccine within the 30 days preceding the first dose of study vaccine, or plans to receive such a drug during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290355

  Show 47 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 249553/004
Study First Received: February 10, 2006
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00290355  
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by GlaxoSmithKline:
MAGE-A3

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009