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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02507154 |
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Date of registration:
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22/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reactivating NK Cells in Treating Refractory Head and Neck Cancer
NKEXPHNC |
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Scientific title:
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Phase I/II Study of Expanded, Activated Autologous Natural Killer Cell Infusions With Cetuximab for Patients With EGFR-Positive Nasopharyngeal Carcinoma or Head and Neck Squamous Cell Carcinoma |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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31 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02507154 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Chwee Ming Lim, MBBS |
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Address:
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Telephone:
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6772 2631 |
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Email:
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chwee_ming_lim@nuhs.edu.sg |
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Affiliation:
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Name:
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Chwee Ming Lim, MBBS |
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Address:
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Telephone:
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6772 2631 |
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Email:
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chwee_ming_lim@nuhs.edu.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Age >21
2. Histologically confirmed diagnosis of EGFR-positive nasopharyngeal carcinoma or EGFR
positive HNSCC (based on >80% immunohistochemistry of biopsy of recurrent tumor
Ventana (Roche) clone 3C6
3. Recurrent cancer that is not surgically salvageable
4. Metastatic disease (after one course of palliative chemotherapy has been completed)
5. Presence of measurable tumor by RECIST 1.1 criteria
6. At least two weeks since receipt of any biological therapy, chemotherapy, and/or
radiation
7. Adequate organ function
8. Haemoglobin = 9g/dL ANC = 1500/µL Platelet count = 100,000/µL Creatinine clearance
=60ml/minute Total bilirubin = 1.5 x upper limit normal (ULN) AST = 5 x upper limit
normal ALT = 2 x upper limit normal INR and PTT <1.5 x upper limit normal (ULN)
9. ECOG performance status of 0-2
10. Life expectancy of at least 60 days
11. Localized radiotherapy for palliative pain management is permissible
12. Written consent to participate on study
13. Physiological dose of steroid replacement is permissible
Exclusion Criteria
1. Treatment within the last 30 days with any investigational drug
2. Hypersensitivity to cetuximab or any excipients of the NK cell product
3. Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy
4. Major surgery within 28 days of study drug administration
5. Radiotherapy to the target lesions during study or within 3 weeks prior to study
treatment.
6. Autologous bone marrow transplant
7. Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy
8. Lactating or pregnant
9. Unwilling to use adequate barrier contraception measures during study period.
10. Second primary malignancy that is clinically detectable at the time of consideration
for study enrolment
11. Receipt of immunosuppressives or steroids (=1mg/kg) during time period of 3 days prior
to expanded NK cell infusion to 30 days after infusion (i.e. day -3 to day +30).
12. Symptomatic brain metastases
13. Electrocardiogram with clinically significant findings.
14. 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
- Poorly controlled hypertension
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nasopharyngeal Cancer
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Head and Neck Squamous Cell Carcinoma
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Intervention(s)
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Drug: Cetuximab + NK cells
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Primary Outcome(s)
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Safety as measured by clinical examination including hematology, renal and liver function tests, adverse events and any significant biochemical abnormalities or toxicities
[Time Frame: 12- 18 weeks]
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Objective tumor response
[Time Frame: Up to 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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