Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma

This study has been terminated.
(Slow enrolment over the last 2 years with none in the past 1 year. No increase in the number of completed subjects for 1 year and no more ongoing study subjects)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00685750
First received: May 23, 2008
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Lung Cancer, Non-Small Cell
Procedure: Collection of tumor and blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Expression of tumor antigens [ Time Frame: Before and after standard treatment ] [ 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 standard treatment ] [ 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 standard treatment ] [ 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 standard treatment ] [ 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 ]

Enrollment: 219
Study Start Date: April 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ME1
Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment
Procedure: 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
Procedure: 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
Procedure: 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
Procedure: Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME5
Patients with cutaneous metastatic melanoma receiving local imiquimod
Procedure: Collection of tumor and blood samples
Samples will be collected before and after standard treatment
NSC
Non-small cell lung cancer patients
Procedure: Collection of tumor and blood samples
Samples will be collected before and after standard treatment
ME6
Patients with cutaneous metastatic melanoma receiving ipilimumab
Procedure: Collection of tumor and blood samples
Samples will be collected before and after standard treatment

Detailed Description:

This protocol posting has been updated due to a protocol amendment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685750

Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90025
United States, Illinois
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
France
GSK Investigational Site
Dijon, France, 21079
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Marseille, France, 13274
GSK Investigational Site
Marseille Cedex 5, France, 13385
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Paris, France, 75012
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Regensburg, Bayern, Germany, 93049
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Ostercappeln, Niedersachsen, Germany, 49179
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
GSK Investigational Site
Berlin, Germany, 12200
GSK Investigational Site
Hamburg, Germany, 20246
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Siena, Toscana, Italy, 53100
GSK Investigational Site
Padova, Veneto, Italy, 35128
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00685750     History of Changes
Other Study ID Numbers: 109752
Study First Received: May 23, 2008
Last Updated: September 18, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by GlaxoSmithKline:
tumor antigen
biomarkers

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014