Breast Cancer Clinical Trial
Official title:
Phase I/II Study of Expanded, Activated Autologous Natural Killer Cell Infusions With Trastuzumab for Patients With HER2+ Breast and Gastric Cancer
This study will determine the safety and efficacy of expanded activated autologous NK cells administered after Trastuzumab in patients with HER2-positive breast or gastric cancer. It will also provide valuable insights of the role of NK cell infusions in adult solid tumors.
Status | Recruiting |
Enrollment | 29 |
Est. completion date | August 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 99 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-65 2. Histologically confirmed diagnosis of HER2-positive breast or gastric cancer (defined as IHC 3+ or HER2 FISH amplification ratio >2.2) 3. Metastatic disease 4. Presence of measurable tumour by RECIST 1.1 criteria 5. 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) 6. At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy 7. Left ventricular ejection fraction =50% 8. 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 9. ECOG performance status of 0-1 10. Life expectancy of at least 60 days 11. Negative serum or urine pregnancy test result within 14 days prior to enrolment for women who are of childbearing potential 12. 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. 13. Patients with reproductive potential must agree to use an approved contraceptive method 14. Ability to comply with study procedures Exclusion Criteria: 1. Treatment within the last 30 days with any investigational drug 2. Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy 3. Major surgery within 28 days of study drug administration 4. Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy 5. Lactating or pregnant. 6. 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 7. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment 8. Symptomatic brain metastases 9. 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). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore | |
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | National University, Singapore |
Singapore,
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. — View Citation
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;29:134. doi: 10.1186/1756-9966-29-134. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Serious and Non-Serious Adverse Events | 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 |
Up to 12-18 weeks | Yes |
Primary | Duration of Tumor Response Measure | 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 | No |
Primary | Time-to-Event Outcome Measure | 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 | No |
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