Reactivating NK Cells in Treating Refractory Head and Neck Cancer

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine the safety and efficacy of expanded activated autologous NK cells administered after cetuximab in patients with EGFR-positive nasopharyngeal carcinoma or head and neck squamous cell carcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Cetuximab

Criteria

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