Last updated: 11/03/2018 10:36:24

Expression analysis of specific markers in non-small cell lung cancer or melanoma

GSK study ID
109752
Clinicaltrials.gov ID
NCT00685750
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Analysis of the expression of a specific set of genes and tumor antigens in patients with non-small cell lung cancer or melanoma
Trial description: This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of markers potentially predictive of clinical response to specific anticancer therapies.
Primary purpose:
Screening
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with expression of tumor antigens

Timeframe: Before and after administration of standard of care treatment course

Number of subjects with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic before and after standard cancer treatment.

Timeframe: Before and after administration of standard of care treatment course

The serum proteome

Timeframe: After administration of standard of care treatment course

Correlation of relevant markers of the pre-identified gene-expression signature as measured by immunohistochemical methods and by quantitative PCR.

Timeframe: After administration of standard of care treatment course

Number of NSCLC patients with gene-expression signature and tumor antigens in distinct concomitant tumor lesions obtained at the same time from the same patient.

Timeframe: After administration of standard of care treatment course

Number of patients responding to treatment, by best clinical response type

Timeframe: At 6 months after the initiation of the ipilimumab therapy

Secondary outcomes:
Not applicable
Interventions:
  • Procedure/surgery: Collection of tumor and blood samples
    • Enrollment:
    88
    Primary completion date:
    2013-17-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Non-Small Cell
    Product
    GSK1711805A
    Collaborators
    Not applicable
    Study date(s)
    April 2008 to December 2013
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • The patient (male or female) is at least 18 years of age.
    • The investigator believes that the patient can and will comply with the requirements of the protocol.
    • The patient has any family history of congenital or hereditary immunodeficiency.
    • The patient has in the two weeks before baseline received any of the following:
    Inclusion and exclusion criteria
    Inclusion criteria:

      The patient (male or female) is at least 18 years of age.

      • The investigator believes that the patient can and will comply with the requirements of the protocol.
      • The patient has given his/her written informed consent to take part in the study.
      • The investigator believes that it will be possible to obtain a tumor tissue sample of at least 3 mm3 before treatment and all required tumor tissues several weeks after the initiation of the treatment.
      • The patient has cancer in one of the following histological types, fulfilling all of the characteristics listed for the respective cancer type: Cutaneous Melanoma, unresectable stage III or stage IV
      • The patient has histologically documented unresectable stage III or stage IV metastatic cutaneous melanoma. AND
      • The patient is a candidate for one of the following treatments:
    • First-line chemotherapy with DTIC or TMZ as monotherapy [group ME1],
    • First-line chemotherapy with an agent other than DTIC/TMZ as monotherapy or a combination (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ) [group ME2],
    • Second- or higherline chemotherapy with any agent or combination of agents (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ ; i.e., systemic chemotherapy after isolated limb perfusion should be considered as second-line) [group ME3],
    • Palliative irradiation of skin lesion(s)/region, irrespective of what line of treatment is planned [group ME4],
    • Topical palliative treatment by imiquimod of skin lesion(s), irrespective of what line of treatment is planned [group ME5].

      • First or higher line treatment with ipilimumab [group ME6]. NSCLC, any stage if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection

      • The patient has NSCLC at any stage (as defined by the International Staging System) if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection. AND
      • The patient is a candidate for chemo(radio)-therapy induction doublet neoadjuvant chemotherapy with platinum plus a second chemotherapy drug. [Note: Induction radiotherapy is permitted.] The recruitment of patients to the NSCLC group has been ended prematurely.
    Exclusion criteria:

      The patient has any family history of congenital or hereditary immunodeficiency.

      • The patient has in the two weeks before baseline received any of the following:
      • Chemotherapeutic agents,
      • Immune-modulating agents such as (but not confined to) IFN-α, IL-2, BCG and anti-cancer therapeutic vaccines,
      • Immunosuppressive agents such as corticosteroids [except for prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day, maximum duration of treatment three weeks), and inhaled and topical steroids, which are allowed].
      • The patient is currently receiving an anti cancer treatment in another clinical trial. However, if the patient has finished the drug administration phase of that trial and has entered the follow-up phase, this patient can be included.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20141
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tuebingen, Baden-Wuerttemberg, Germany, 72076
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Park Ridge, Illinois, United States, 60068
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Freiburg, Baden-Wuerttemberg, Germany, 79106
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hemer, Nordrhein-Westfalen, Germany, 58675
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68167
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 34 Results

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2013-17-12
    Actual study completion date
    2013-17-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website