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

Lung Cancer, Non-Small Cell Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00685750
• Other study ID #: 109752
• Status: Terminated
• Phase: N/A
• Start date: April 28, 2008
• Est. completion date: December 17, 2013

Study information

• Verified date: March 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 17, 2013
• Est. primary completion date: December 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 IFN?) [group ME2],

• Second- or higherline chemotherapy with any agent or combination of agents (that may, but need not, include DTIC, TMZ, IL-2 or IFN? ; 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-a, 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Lung Neoplasms

Intervention

Procedure:
• Collection of tumor and blood samples
Samples will be collected before and after standard treatment

Locations

Country	Name	City	State
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille Cedex 5
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Greifswald	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hemer	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ostercappeln	Niedersachsen
Germany	GSK Investigational Site	Regensburg	Bayern
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuerzburg	Bayern
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Siena	Toscana
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Stockholm
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Expression of Tumor Antigens	The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration	Before and after administration of standard of care treatment course, up to 3 months
Primary	Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic	The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.	Before and after administration of standard of care treatment course, up to 3 months
Primary	The Serum Proteome		After administration of standard of care treatment course
Primary	Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.		After administration of standard of care treatment course
Primary	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.		After administration of standard of care treatment course
Primary	Number of Patients Responding to Treatment, by Best Clinical Response Type	This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.	At 6 months after the initiation of the ipilimumab therapy