Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in (SG-AAA-II-01)

This is an interventional treatment trial for Metastatic Nasopharyngeal Cancer focused on measuring Peptide Receptor Radionuclide therapy (PRRT), 177Lu-DOTA0-Tyr3-Octreotate, Radionuclide therapy, Metastatic Nasopharyngeal Carcinoma, Theragnostics Read More

Inclusion Criteria:

• a histologically confirmed diagnosis of NPC
• metastatic NPC that has failed two or more lines of therapy or exhausted standard therapy
• an Eastern Cooperative Oncology Group performance status of 0-2
• age 21-75 years, a life expectancy of more than 3 months
• no prior use of radionuclide therapy
• no prior radiotherapy to more than 25% of bone marrow
• less than 50% of bone marrow involved on 68Ga-DOTATATE scan
• Krenning score ≥ 3 and at least 75% concordance between 68Ga-DOTATATE scan and 18F-FDG PET scan
• at least 1 bidimensionally measurable (2 cm) site of disease.
• A wash-out period of at least 3 weeks from the last dose of prior chemotherapy is required before the administration of the first dose of 177Lu-DOTATATE.
• adequate hematologic, renal, and liver function using standard laboratory measurements
• no history of other malignancy, except treated basal cell and squamous cell skin carcinomas

Exclusion Criteria:

• Serum creatinine >120 μmol/L or 1.2 mg/dL, or a measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) of <50 mL/min.
• Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <3x10^9/L (3000/mm3); platelets <75x10^9/L (75x10^3/mm3).
• Total bilirubin >3 x ULN.
• Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
• Pregnancy (see protocol Appendix 6).
• For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) as defined in Appendix 6.
• Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.
• Targeted surgery, radiotherapy (external beam), chemotherapy, embolization, interferons, mTOR-inhibitors or other investigational therapy within 3 weeks prior to enrolment in the study.
• Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases should have a head CT/MRI to document stable disease prior to enrolment in the study.
• Uncontrolled congestive heart failure (NYHA II, III, IV).
• Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
• Any patient receiving treatment with short or long acting somatostatin analogs.
• Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
• Urinary incontinence.
• Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
• Patients who have not provided a signed an informed consent form to participate in the study, obtained prior to the start of any protocol related activities.
• Patients who are unable to comply with relevant contact precautions post Lutetium therapy.
• Patients with a synchronous local nasopharyngeal recurrence, with prior high-dose irradiation to the primary tumour.
• Patients with active Hepatitis B (HBsAg positive) or Hepatitis C (HCV Ab positive) infection will be excluded.
• Patients with known history of Human Immunodeficiency Virus (HIV) will be excluded.