Status:
UNKNOWN
Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in
Lead Sponsor:
National Cancer Centre, Singapore
Collaborating Sponsors:
Novartis
Advanced Accelerator Applications
Conditions:
Metastatic Nasopharyngeal Cancer
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
This study is the first phase II study of 177Lu-DOTA0-Tyr3-Octreotate in metastatic NPC. Patients whom have failed 2 or more lines of therapy or exhausted standard therapy and are avid on 68Ga-DOTATAT...
Detailed Description
This would be an open label, single arm, single centre, phase II study designed to evaluate the efficacy of 177Lu-DOTA0-Tyr3-Octreotate in Metastatic NPC. Patients will first need to go for a 68Ga-DO...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05198479
Start Date
May 5 2023
End Date
September 30 2025
Last Update
October 11 2023
Active Locations (2)
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1
National Cancer Centre Singapore
Singapore, Singapore
2
Singapore General Hospital
Singapore, Singapore