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Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Non-Small Cell

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Trial Information

Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Expression of tumor antigens

Outcome Time Frame:

Before and after standard treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Germany: Ethics Commission

Study ID:

109752

NCT ID:

NCT00685750

Start Date:

April 2008

Completion Date:

January 2014

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • tumor antigen
  • biomarkers
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Melanoma

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteSalt Lake City, Utah  84107