- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02030561
NK Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
Phase I/II Study of Expanded, Activated Autologous Natural Killer Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Soo Chin Lee, MBBS
- Phone Number: (65) 6779 5555
- Email: soo_chin_lee@nuhs.edu.sg
Study Contact Backup
- Name: Joan Phee
- Phone Number: (65) 6772 2404
- Email: Joan_Phee@nuhs.edu.sg
Study Locations
-
-
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Singapore, Singapore, 119228
- Recruiting
- National University Hospital
-
Contact:
- Soo Chin Lee, MBBS
- Phone Number: +65 6779 5555
- Email: soo_chin_lee@nuhs.edu.sg
-
Sub-Investigator:
- Dario Campana, MBBS
-
Singapore, Singapore, 119228
- Not yet recruiting
- National University Hospital
-
Contact:
- Soo Chin Lee, MBBS
- Phone Number: (65) 6779 5555
- Email: soo_chin_lee@nuhs.edu.sg
-
Principal Investigator:
- Soo Chin Lee, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65
- Histologically confirmed diagnosis of HER2-positive breast or gastric cancer (defined as IHC 3+ or HER2 FISH amplification ratio >2.2)
- Metastatic disease
- Presence of measurable tumour by RECIST 1.1 criteria
- Must have failed at least two lines of trastuzumab-containing systemic therapy (documented relapse while receiving adjuvant or neoadjuvant trastuzumab for HER2 positive breast cancer is eligible)
- At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy
- Left ventricular ejection fraction ≥50%
- Adequate organ function ANC ≥ 1500/µL Platelet count ≥ 100,000/µL Creatinine clearance ≥60ml/minute Total bilirubin ≤ 1.5 x upper limit normal (ULN) AST ≤ 2 x upper limit normal ALT ≤ 2 x upper limit normal
- ECOG performance status of 0-1
- Life expectancy of at least 60 days
- Negative serum or urine pregnancy test result within 14 days prior to enrolment for women who are of childbearing potential
- Ability to provide informed consent. Otherwise, a legally authorized representative (LAR) must be present throughout the consent process and is allowed to give consent on the patient's behalf.
- Patients with reproductive potential must agree to use an approved contraceptive method
- Ability to comply with study procedures
Exclusion Criteria:
- Treatment within the last 30 days with any investigational drug
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy
- Major surgery within 28 days of study drug administration
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Lactating or pregnant.
Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; serious cardiac illness or medical conditions including but not limited to:
- Patients with dyspnea at rest.
- History of documented congestive heart failure
- High risk uncontrolled arrhythmias
- Angina pectoris requiring a medicinal product
- Clinically significant valvular disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment
- Symptomatic brain metastases
- Receipt of steroids during time period of 3 days prior to expanded NK cell infusion to 30 days after infusion (i.e. day -3 to day +30).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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 |
Up to 12-18 weeks
|
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.
|
Up to 36 months
|
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.
|
Up to 36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Soo Chin Lee, MBBS, National University Hospital, Singapore
Publications and helpful links
General Publications
- Beano A, Signorino E, Evangelista A, Brusa D, Mistrangelo M, Polimeni MA, Spadi R, Donadio M, Ciuffreda L, Matera L. Correlation between NK function and response to trastuzumab in metastatic breast cancer patients. J Transl Med. 2008 May 16;6:25. doi: 10.1186/1479-5876-6-25.
- Voskens CJ, Watanabe R, Rollins S, Campana D, Hasumi K, Mann DL. Ex-vivo expanded human NK cells express activating receptors that mediate cytotoxicity of allogeneic and autologous cancer cell lines by direct recognition and antibody directed cellular cytotoxicity. J Exp Clin Cancer Res. 2010 Oct 11;29(1):134. doi: 10.1186/1756-9966-29-134.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC01/21/13
- 2013/00566 (Other Identifier: Singapore NHG Domain Specific Review Boards)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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