Pemetrexed for advanced thymic epithelial tumors

Not Applicable

Not yet recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004180
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-08-26
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Patients have any histologically-confirmed inoperable/advanced/metastatic solid tumor (except non-small cell lung cancer) by pathology report and have received, been intolerantTET who progressed after treated with first line cisplatinplatinum containing chemotherapy (not more than two line). to, been ineligible for or refused all treatment known to confer clinical benefit.chemotherapy AND achieved objective response (SD, PR, or CR)
Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at Asan Medical Center.
Tumor with ALK IHC positive and ALK FISH positive = 1 unidimensionally measurable lesion as defined by RECIST v1.1
After ALK test by Ventana IHC (Appendix 2), patient samples will also be tested by FISH Vysis® ALK Break Apart FISH Probe Kit (Abbott).
Age =18 years old
Lift expectancy of at least 12 weeks
ECOG PS of 0-2
Adequate hematologic function
Platelet count = 100 x 109/L
ANC =1500 cells/uL
Hemoglobin = 9.0 g/dL
Adequate renal function: An estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease equation of at least 45 mL/min/1.73 m2
Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment.
Adequate hematologic function
Measurable disease (by RECIST v1.1) prior to the administration of study treatment
Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic CNS lesions might be treated at the discretion of the investigator as per local clinical practice. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable.
For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment.
Able and willing to provide written informed consent prior to performing any study-related procedures

Exclusion Criteria

?TET with neuroendocrine feature or small cell histology
?Prior participation in a study investigating pemetrexed or practical treatment with pemetrexed
?Serious cardiac condition, such as myocardial infarction, angina, or heart disease
?Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in PFS and OS for the current malignancy).
? Liver disease characterized by:
–ALT or AST > 3 × ULN (= 5 × ULN for patients with concurrent liver metastasis) confirmed on two consecutive measurements
OR
–Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices
?National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
?History of organ transplant
?Pregnant or lactating women
?Known HIV positivity or AIDS-related illness

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified