Status:
TERMINATED
Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
NA
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 obtai...
Detailed Description
This protocol posting has been updated due to a protocol amendment.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00685750
Start Date
April 28 2008
End Date
December 17 2013
Last Update
June 20 2019
Active Locations (34)
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1
GSK Investigational Site
Los Angeles, California, United States, 90025
2
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
3
GSK Investigational Site
St Louis, Missouri, United States, 63110
4
GSK Investigational Site
Murray, Utah, United States, 84107