Status:
TERMINATED
Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment
Lead Sponsor:
Western Regional Medical Center
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aim 1 - Launch Pilot Study. In this aim, the investigators seek to launch a pilot study and enroll 12 eligible patients with advanced small cell lung cancer (SCLC) and to obtain the necessary tumor bi...
Detailed Description
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant. Blood wi...
Eligibility Criteria
Inclusion
- Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- Life expectancy \> 3 months
- Karnofsky Performance Status ≥ 70
- Diagnosis of histological or cytologically confirmed advanced, incurable SCLC, which has progressed on one or more prior chemotherapeutic, hormonal, or biological regimens for advanced SCLC
- Age ≥ 18 years
- Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin \> 9 g/dL; platelets \> 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0
- Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Exclusion
- Symptomatic CNS metastasis. Patients with a history of CNS metastases, who have been treated, must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- Known HIV, HBV, or HCV infection requiring antiviral therapy.
- Pregnant or breastfeeding patients or any patient of childbearing potential not using adequate contraception.
- Tumor inaccessible for biopsy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02297087
Start Date
October 1 2014
End Date
October 1 2017
Last Update
November 9 2017
Active Locations (1)
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1
Cancer Treatment Center of America @ Western Regional Medical Center
Goodyear, Arizona, United States, 85338