Status:
COMPLETED
Haploidentical NK Cells After Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korea Research Institute of Bioscience & Biotechnology
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This phase 1 trial investigate safety and maximum tolerated dose of natural killer (NK) cells derived from haploidentical family donors in patients with non-small cell lung cancer
Detailed Description
Eligible patients receive pemetrexed 500 mg/m2 intravenously (Day 1). On Day 8, patients receive donor-derived NK cells via a central venous catheter. The NK cell dose is as follows; Level 1: 1.25 X...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed non-small cell lung cancer stage 4 (by AJCC 7th)
- Age, 20 years of age or older
- ECOG performance status, 0-2
- Life expectancy ≥3 months
- Patients should have at least one measurable lesion according to RECIST Criteria v1.1
- Failure after primary systemic treatment with a regimen including platinum-containing agent (primary systemic treatment may be adjuvant chemotherapy or chemo-radiotherapy, given within 12 months)
- Adequate bone marrow function (Hb ≥9 g/dL; ANC ≥1,500/uL; and platelet count ≥75,000/uL)
- Adequate renal function (serum creatinine \<1 x ULN or CLcr ≥45 mL/min by Cockroft and Gault formula
- Adequate liver function (total bilirubin \<1.5 x ULN; AST and ALT \<3 x ULN; and ALP \<3 x ULN, unless there is bone metastases without evidence of liver disease)
- Patients should have a suitable HLA-haploidentical family member who is willing to donate hematopoietic stem cells
- Patients should sign informed consent voluntarily
Exclusion
- Patients who received anti-cancer chemotherapeutic or biological agents within 3 weeks. Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTC AE ver 4.0 are not eligible as well.
- Patients with contraindication for any medication planned to be administered in the study
- Patients with significant fluid accumulation in third space (for example, pleural or pericardial effusion) that can not be controlled by drainage
- Active infectious process
- Inability to discontinue aspirin over 1.3 g daily or other NSAIDs. Patients cannot take aspirin or NSAIDs within 5 days of pemetrexed administration
- Major surgery within 4 weeks of study participation
- Palliative radiation therapy within 1 week of study participation
- Acute myocardial infarction within 6 months of study participation. History of uncontrolled arrhythmia, symptomatic angina, or symptomatic heart failure
- Past or current history of CNS metastasis (with exception of those patients who completed treatment of CNS metastasis and not received steroid treatment or whole brain radiotherapy within 2 weeks of screening visit or not received gamma knife treatment within 1 week of screening visit)
- History of malignancy (other than skin basal cell carcinoma, carcinoma in situ of uterine cervix, or thyroid cancer) within 5 years
- Pregnant or lactating women. Child-bearing women who are not willing to avoid pregnancy by contraceptives
- Man not agreeing to contraceptive measures such as condom or abstinence (It is recommended that contraceptive measures be used until 6 months after pemetrexed treatment)
- Other serious illness or medical condition
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03366064
Start Date
November 9 2017
End Date
June 15 2019
Last Update
July 8 2019
Active Locations (1)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736