Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in

Launched by NATIONAL CANCER CENTRE, SINGAPORE · Jan 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 177Lu-DOTATATE for patients with metastatic nasopharyngeal cancer (NPC), which means the cancer has spread beyond its original site. This study is specifically for patients who have already tried two or more treatments that didn’t work or who have run out of standard treatment options. To be eligible, participants must be between 21 and 75 years old, have a confirmed diagnosis of NPC, and show certain results on imaging tests that indicate they might benefit from this therapy.

If someone joins the trial, they can expect to receive up to four cycles of the treatment and will be monitored closely for their health during the study. The main goal is to see how long the treatment helps keep the cancer from getting worse in the first six months. It’s important to note that participants will need to meet specific health criteria and undergo tests before enrolling, and they should not have had certain other treatments or health issues that could affect their safety during the trial.

Gender

ALL

Eligibility criteria

• 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.