Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02370017
Status:
UNKNOWN
Last Update Posted:
2017-02-03
First Post:
2015-02-01
Brief Title:
Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment
Sponsor:
The Catholic University of Korea
Organization:
The Catholic University of Korea
Study Overview
Official Title:
Combined Effect of Autologous Ex-vivo Expanded Activated NK Cell-lymphocytes ANKL and Doublet Chemotherapy in Patients With Advanced NSCLC as the 1st Line Treatment Phase II
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANKL-2
Brief Summary:
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy ANKL 2x109 from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained After 4th course response evaluation is done by Response Evaluation Criteria in Solid Tumors RECIST and 40 or more partial response PR increased by 15 or more from historical control 25 is the expected target and Simons two stage design will be applied through the study power 80 a 095 N1 33 N 68
Detailed Description:
Based on additive or synergistic effect of natural killer NK cell and chemotherapy modulating the expression of NK stimulatory ligand on tumor cell the investigators performed phase II trial of docetaxel and ANKL combination s the second line treatment in advanced non-small cell lung cancer NSCLN and reported the results in May 2013 Anticancer Research 332115 Poster Presentation in ASCOIn that study the investigators observed the feasibility and safety of ANKL combined with docetaxel in patients with advanced NSCLC but the clinical benefit was not evaluated properly because the study was interrupted unintentionally and most of the enrolled patients were far advanced with large tumor burden that is poor immunological environment for ANKL to work
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC The approved doublet chemotherapy based on platinum is widely used with the response rate RR 25-35 after 4-6 courses as the first line treatment The investigators design the combination of ANKL and chemotherapy as the 3rd and 4th courses in the patients who show stable response after x2 courses Higher RR with the combination treatment is the primary outcome as compared with the chemotherapy alone - historical control about 12 PR and 50 stable response after x2 initial courses and 25 PR after x2 more courses among the patients who get stable response after x2 initial courses Peripheral blood 32 ml will be drawn from the patients who decide to be enrolled and about 2 weeks later ANKL 2x109 are scheduled to be administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained After 4th course response evaluation is done by RECIST and 40 or more PR increased by 15 or more from historical control 25 is the expected target and Simons two stage design will be applied through the study power 80 a 095 N1 33 N 68
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC The approved doublet chemotherapy based on platinum is widely used with the response rate RR 25-35 after 4-6 courses as the first line treatment The investigators design the combination of ANKL and chemotherapy as the 3rd and 4th courses in the patients who show stable response after x2 courses Higher RR with the combination treatment is the primary outcome as compared with the chemotherapy alone - historical control about 12 PR and 50 stable response after x2 initial courses and 25 PR after x2 more courses among the patients who get stable response after x2 initial courses Peripheral blood 32 ml will be drawn from the patients who decide to be enrolled and about 2 weeks later ANKL 2x109 are scheduled to be administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained After 4th course response evaluation is done by RECIST and 40 or more PR increased by 15 or more from historical control 25 is the expected target and Simons two stage design will be applied through the study power 80 a 095 N1 33 N 68
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None