177Lu-DOTATATE treatment for metastatic nasopharyngeal cancer

A Biomarker Enrichment, Phase II Study of 177Lu-DOTATATE in Metastatic Nasopharyngeal Cancer With a Safety Run-in

This study is testing a new treatment for people with advanced nasopharyngeal cancer who haven't had success with previous therapies to see if it helps them live longer without their cancer getting worse.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: National Cancer Centre, Singapore (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Singapore and 1 other locations)
• Trial ID: NCT05198479 on ClinicalTrials.gov

What this trial studies

This phase II study evaluates the efficacy of 177Lu-DOTA0-Tyr3-Octreotate in patients with metastatic nasopharyngeal cancer who have failed two or more lines of therapy. Eligible patients will undergo a 68Ga-DOTATATE scan to confirm suitability for treatment. The study will recruit 25 patients and assess progression-free survival at 6 months, with a focus on safety and tolerability of the treatment regimen. The design includes a safety run-in phase to monitor for toxicities before proceeding with the full treatment protocol.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-75 with histologically confirmed metastatic nasopharyngeal cancer who have exhausted standard therapies.

Not a fit: Patients with significant renal impairment or those who have previously received radionuclide therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced nasopharyngeal cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is novel for metastatic nasopharyngeal cancer, similar radionuclide therapies have shown promise in other malignancies.

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.

Where this trial is running

Singapore and 1 other locations

• National Cancer Centre Singapore — Singapore, Singapore (RECRUITING)
• Singapore General Hospital — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Daniel Tan, BSc, MBBS, PhD — National Cancer Centre, Singapore
• Study coordinator: Daniel Tan, BSc, MBBS, PhD

Conditions: Metastatic Nasopharyngeal Cancer, Peptide Receptor Radionuclide therapy, 177Lu-DOTA0-Tyr3-Octreotate, Radionuclide therapy, Metastatic Nasopharyngeal Carcinoma, Theragnostics