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  • CARPETS

    Acronym: 

    CARPETS

    ACTRN/NCT /ethics: 

    ACTRN12613000198729

    Scientific title: 

    Study of increasing doses of genetically modified GD2-specific T cells in patients with metastatic melanoma

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I Tumour Stream Melanoma
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2013-03-29
    Molecular Target Anticipated End Date
    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Melanoma
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2013-03-29
    Anticipated End Date

    Trial Summary

    The main aim of this Phase I study is to assess the safety and immune effects of using autologous peripheral blood T cells in GD2 positive patients being treated with vemurafenib. Oral kinase inhibitors are proving to be effective in the up to 60% of malignant melanomas that are found to have a BRAF mutation. However, drug resistance is emerging and many patients relapse affirming the need for further treatment development. Who is this study for and who is it open to? This study is for patients with metastatic melanoma who are BRAF V600E or V600K positive and who are eligible to receive vemurafenib. Patients who consent to the study will be asked permission to test their archived melanoma tissue for GD2 expression. If this test returns a positive result, the patient may then continue with the trial. What will the patients receive? Patients will receive vemurafenib at a dose of 960mg twice daily (b.d.) during the 4 to 6 week period in which the T-cell product is being prepared. Once produced, the T-cell product will be given as a single intravenous infusion at a dose relevant to the cohort that the patient has been assigned to. The patient will then be monitored as per the follow up schedule specified by the study protocol.

    Lay Summary

    Study of increasing doses of genetically modified GD2-specific T cells in patients with metastatic melanoma

    Sponsor / Cooperative group

    Royal Adelaide Hospital

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Professor Michael Brown Recruiting
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Recruiting