Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma
NCT ID: NCT00685750
Last Updated: 2019-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
NA
88 participants
INTERVENTIONAL
2008-04-28
2013-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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ME1
Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME2
Patients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME3
Patients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME4
Patients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME5
Patients with cutaneous metastatic melanoma receiving local imiquimod
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
NSC
Non-small cell lung cancer patients
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME6
Patients with cutaneous metastatic melanoma receiving ipilimumab
Collection of tumor and blood samples
Samples will be collected before and after standard treatment
Interventions
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Collection of tumor and blood samples
Samples will be collected before and after standard treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Park Ridge, Illinois, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Murray, Utah, United States
GSK Investigational Site
Dijon, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Regensburg, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Ostercappeln, Lower Saxony, Germany
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Hemer, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Siena, Tuscany, Italy
GSK Investigational Site
Padua, Veneto, Italy
GSK Investigational Site
Gothenburg, , Sweden
GSK Investigational Site
Lund, , Sweden
GSK Investigational Site
Stockholm, , Sweden
Countries
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Other Identifiers
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109752
Identifier Type: -
Identifier Source: org_study_id
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