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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00685750
First received: May 23, 2008
Last updated: July 3, 2014
Last verified: July 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 ]

Estimated Enrollment: 160
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

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 35 Study Locations
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: July 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by GlaxoSmithKline:
tumor antigen
biomarkers

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Melanoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 26, 2014