NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02030561|
Recruitment Status : Unknown
Verified June 2016 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : January 8, 2014
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Gastric Cancer||Drug: Trastuzumab + NK cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Expanded, Activated Autologous Natural Killer Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2018|
Experimental: Trastuzumab + NK cells
During cycle 1, Day 1 patient will receive intravenous trastuzumab and subcutaneous IL-2 on day 1, followed by NK cell infusion on day 2, followed by subcutaneous IL-2 for an additional 5 doses three times a week to support NK cell viability and expansion in vivo.
From cycles 2-4, patient will receive trastuzumab monotherapy alone every 21 days, except for patients who achieve objective tumor response after 2 cycles of therapy, who will then receive an additional infusion of NK cells along with trastuzumab during cycle 4 therapy at the same dose and schedule as in cycle 1.
Patients will be taken off study after cycle 4, unless the patient has objective tumor response after 4 cycles of therapy with only stable disease after cycle 2, in which case the patient will be given another 2 cycles of trastuzumab with an additional NK cell infusion during cycle 6 therapy at the same dose and schedule as in cycle 1.
Drug: Trastuzumab + NK cells
Other Name: Herceptin
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 12-18 weeks ]
During cycle 1 (21 days) and for at least 21 days following a second NK cell infusion if administered:
- Patients will be reviewed twice a week with
- Limited physical examination to include blood pressure, heart rate, weight
- Full blood count, renal function and liver function tests
- Toxicity rating using the NCI CTC scale
- Concomitant medication notation and number of units required for transfusions
Any significant abnormalities or significant toxicities have to be followed until recovery to baseline or 30 days after patient withdraws from the study, whichever occurs later.
During other cycles when only trastuzumab is administered (without NK cells infusion or IL-2) Patients will be reviewed once every cycle of every 3-weekly cycle
- Duration of Tumor Response Measure [ Time Frame: Up to 36 months ]Among tumor responders, the duration of tumor response is measured from the date of enrolment until the first date of documented disease progression or death due to any cause, whichever occurs first. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.
- Time-to-Event Outcome Measure [ Time Frame: Up to 36 months ]Time to documented disease progression is defined as the time from the date of enrolment to the first date of documented disease progression. Time to documented disease progression will be censored at the date of death for patients who have not had documented disease progression. For patients who are still alive at the time of analysis and who have not had documented disease progression, time to documented disease progression will be censored at the date of the last follow-up visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030561
|Contact: Soo Chin Lee, MBBS||(65) 6779 5555||Soo_Chin_Lee@nuhs.edu.sg|
|Contact: Joan Phee||(65) 6772 2404||Joan_Phee@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Soo Chin Lee, MBBS +65 6779 5555 Soo_Chin_Lee@nuhs.edu.sg|
|Sub-Investigator: Dario Campana, MBBS|
|National University Hospital||Not yet recruiting|
|Singapore, Singapore, 119228|
|Contact: Soo Chin Lee, MBBS (65) 6779 5555 Soo_Chin_Lee@nuhs.edu.sg|
|Principal Investigator: Soo Chin Lee, MBBS|
|Principal Investigator:||Soo Chin Lee, MBBS||National University Hospital, Singapore|