A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

1. To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK cells in patients with metastatic NPC

2. To demonstrate the safety of low dose systemic IL-2 in combination with escalating doses of autologous Ex Vivo Activated NK cells in patients with metastatic NPC

3. To assess immune measurements such as quantitation of regulatory T cells, EBV specific T cells, serum cytokine levels, and NK cell function after treatment with IL-2 and autologous Ex Vivo Activated NK cells

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

Details

• Lead Sponsor: National University Hospital, Singapore

Criteria

Inclusion Criteria:

• Biopsy proven, metastatic nasopharyngeal carcinoma (NPC) (WHO grade III) and measurable metastatic disease.

• ECOG performance status <2.

• Life expectancy greater than 6 months.

• Patient must have adequate access for leukapheresis (vein or central line)

• Patients must have normal organ and marrow function as defined below:

1. leukocytes >3,500/μl, absolute neutrophil count >1,500/μl, platelets >100,000/μl.

2. Organ function tests:

3. total bilirubin <1.5X normal, AST(SGOT) / ALT(SGPT) <2.5 X of normal or <5X in the case of patients with liver metastases;

4. creatinine <1.5X normal institutional limits or a calculated creatinine clearance of > 50 mls/min.

• Negative pregnancy test within 4 weeks of enrollment in women of child-bearing age.

• Patients with fertility/child bearing potential must agree to avoid pregnancy.

• Age 18 and older

• Patients must have received at least one prior systemic treatments for "metastatic nasopharyngeal carcinoma".Neoadjuvant chemotherapy or concurrent chemoradiation administered for localized disease does is not considered a line of prior treatment.

• Patient's last dose of systemic chemotherapy must have been given at least 4 weeks prior to the beginning of study treatment. Local radiation therapy will be allowed only if there are other sites of measurable disease.

• Patients must have at least one site of measurable disease. Sites of measurable disease which has been irradiated can be used if greater than 60 days has passed between the completion of radiation treatment and the start of NK cell treatment.

Exclusion Criteria:

• Patients with active infections requiring oral or intravenous antibiotics are not eligible for entry onto the study until resolution of the infection.

• History of HIV infection, chronic active Hepatitis B or C.

• Patients with prior or currently active autoimmune disease requiring management with systemic immunosuppression are not eligible. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.

• Enrollment on another experimental treatment within 28 days of starting treatment on this study.

• Systemic steroids within 28 days of starting study treatment.

• Uncontrolled medical problems.