Study on Melanoma - New Research for Cancer Patients

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1 A service of the U.S. National Institutes of Health Trial record 7 of 203 for: Melanoma Analysis Previous Study Return to List Next Study Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma This study is currently recruiting participants. Verified November 2012 by GlaxoSmithKline Sponsor: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline ClinicalTrials.gov Identifier: NCT First received: May 23, 2008 Last updated: April 25, 2013 Last verified: November 2012 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose This study intends to analyze the expression of specific sets of markers in tumor 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. Condition Lung Cancer, Non-Small Cell Intervention Study Type: Study Design: Official Title: Interventional Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma Resource links provided by NLM: MedlinePlus related topics: Cancer Lung Cancer Melanoma U.S. FDA Resources Further study details as provided by GlaxoSmithKline: Primary Outcome Measures: Expression of tumor antigens [ Time Frame: Before and after ] [ Designated as safety issue: No ] Occurrence of a pre-defined gene-expression signature to Antigen-Specific Cancer Immunotherapeutic [ Time Frame: Before and after standard treatment ] [ Designated as safety issue: No ] The serum proteome [ Time Frame: Before and after ] [ Designated as safety issue: No ] Correlation of relevant markers of the pre-identified gene-expression signature as measured by immunohistochemical methods and by quantitative PCR. [ Time Frame: Before and after ] [ Designated as safety issue: No ] For NSCLC patients (where possible), the consistency of the occurrence of the gene-expression signature and tumor antigens in distinct concomitant tumor lesions obtained at the same time from the same patient. [ Time Frame: Single timepoint after ] 1 of 6 6/1/13 6:49 PM

2 [ Designated as safety issue: No ] For metastatic melanoma patients treated with ipilimumab explore predictive value to clinical activity of pre-identified immune-related gene-expression signature by evaluating the patient's best clinical response to this treatment. [ Time Frame: During patient's standard visits to the institution over a period of approximately 6 months after the initiation of the ipilimumab therapy. ] [ Designated as safety issue: No ] Estimated Enrollment: 160 Study Start Date: April 2008 Estimated Study Completion Date: January 2014 Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure) Arms ME1 Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment ME2 Patients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only ME3 Patients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment ME4 Patients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions ME5 Patients with cutaneous metastatic melanoma receiving local imiquimod NSC Non-small cell lung cancer patients ME6 Patients with cutaneous metastatic melanoma receiving ipilimumab Assigned Interventions Detailed Description: This protocol posting has been updated due to a protocol amendment. Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No 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 2 of 6 6/1/13 6:49 PM

3 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. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT Contacts Locations United States, California Los Angeles, California, United States, United States, Illinois Park Ridge, Illinois, United States, United States, Missouri 3 of 6 6/1/13 6:49 PM

4 St. Louis, Missouri, United States, United States, Utah France Murray, Utah, United States, Dijon, France, Lille, France, Marseille Cedex 5, France, Montpellier, France, Germany Nantes, France, Freiburg, Baden-Wuerttemberg, Germany, Mannheim, Baden-Wuerttemberg, Germany, Tuebingen, Baden-Wuerttemberg, Germany, Regensburg, Bayern, Germany, Wuerzburg, Bayern, Germany, Hannover, Niedersachsen, Germany, of 6 6/1/13 6:49 PM

5 Italy Koeln, Nordrhein-Westfalen, Germany, Mainz, Rheinland-Pfalz, Germany, Kiel, Schleswig-Holstein, Germany, Napoli, Campania, Italy, Milano, Lombardia, Italy, Siena, Toscana, Italy, Padova, Veneto, Italy, Padova, Veneto, Italy, Sponsors and Collaborators GlaxoSmithKline Investigators Study Director: GSK Clinical Trials GlaxoSmithKline More Information No publications provided Completed Responsible Party: GlaxoSmithKline ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: Study First Received: May 23, 2008 Last Updated: April 25, 2013 Health Authority: Germany: Ethics Commission Keywords provided by GlaxoSmithKline: tumor antigen biomarkers Additional relevant MeSH terms: Melanoma Nevi and Melanomas Neoplasms Lung Diseases 5 of 6 6/1/13 6:49 PM

6 Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue ClinicalTrials.gov processed this record on May 30, of 6 6/1/13 6:49 PM