Clinical trial NCT00685750: Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer, Non-Small Cell
Keywords: tumor antigen
biomarkers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: This protocol posting has been updated due to a protocol amendment.

Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Expression of Tumor Antigens
timeFrame: Before and after administration of standard of care treatment course, up to 3 months
measure: Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic
timeFrame: Before and after administration of standard of care treatment course, up to 3 months
measure: The Serum Proteome
timeFrame: After administration of standard of care treatment course
measure: Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.
timeFrame: After administration of standard of care treatment course
measure: Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.
timeFrame: After administration of standard of care treatment course
measure: Number of Patients Responding to Treatment, by Best Clinical Response Type
timeFrame: At 6 months after the initiation of the ipilimumab therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Park Ridge
country: United States
facility: GSK Investigational Site
state: Illinois
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Dijon
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Marseille Cedex 5
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Greifswald
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Ostercappeln
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hemer
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Siena
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: