Last updated: 11/03/2018 10:36:24
Expression analysis of specific markers in non-small cell lung cancer or melanoma
GSK study ID
109752
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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
Trial description: 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.
Primary purpose:
Screening
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with expression of tumor antigens
Timeframe: Before and after administration of standard of care treatment course
Number of subjects with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic before and after standard cancer treatment.
Timeframe: Before and after administration of standard of care treatment course
The serum proteome
Timeframe: After administration of standard of care treatment course
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
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
Number of patients responding to treatment, by best clinical response type
Timeframe: At 6 months after the initiation of the ipilimumab therapy
Secondary outcomes:
Not applicable
Interventions:
Procedure/surgery: Collection of tumor and blood samples
Enrollment:
88
Observational study model:
Not applicable
Primary completion date:
2013-17-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
GSK1711805A
Collaborators
Not applicable
Study date(s)
April 2008 to December 2013
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 any family history of congenital or hereditary immunodeficiency.
- The patient has in the two weeks before baseline received any of the following:
Inclusion and exclusion criteria
Inclusion criteria:
- 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].
- 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.
The patient (male or female) is at least 18 years of age.
First or higher line treatment with ipilimumab [group ME6]. NSCLC, any stage if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection
Exclusion criteria:
- 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.
The patient has any family history of congenital or hereditary immunodeficiency.
Trial location(s)
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Ostercappeln, Niedersachsen, Germany, 49179
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Murray, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2013-17-12
Actual study completion date
2013-17-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website