Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
Lead Sponsor:
Advanced Accelerator Applications
Conditions:
Gastroenteropancreatic Neuroendocrine Tumors
Pheochromocytoma
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs...
Detailed Description
The study schedule for each patient consists of the screening period (up to 2 weeks) followed by the treatment period (4 treatment administrations at 8-week interval), and the follow-up period (10 yea...
Eligibility Criteria
Inclusion
- Key
- GEP-NET cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =\< 20%), well differentiated GEP-NET.
- or PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL.
- Patients from 12 to \< 18 years of age at the time of enrollment.
- Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.
- Performance status as determined by Karnofsky score \>= 50 or Lansky Play-Performance Scale score \>= 50.
- Parent's ability to understand and the willingness to sign a written informed consent document for adolescents as determined by local regulations. Adolescents will sign assent along with parental/legal guardian consent or will co-sign consent with parent/legal guardian in accordance with local regulation, prior to participation in the study.
- Key
Exclusion
- Laboratory parameters:
- Estimated creatinine clearance calculated by the Cockroft-Gault method \< 70 mL/min
- Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<2x109/L; platelets \<75x109/L.
- Total bilirubin \>3 x ULN for age.
- Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range.
- Established or suspected pregnancy.
- Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug.
- Female patients of child-bearing potential, unless they are using highly effective methods of contraception during treatment and for 6 months after the last dose of Lutathera.
- Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception.
- Patients for whom in the opinion of the investigator other therapeutic options are considered more appropriate than the therapy offered in the study, based on patient and disease characteristics.
- Current spontaneous 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.
- Hypersensitivity to the study drug active substance or to any of the excipients.
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.
- Patient with known incompatibility to CT Scans with I.V. contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded.
- Patients who received any investigational agent within the last 30 days.
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2034
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04711135
Start Date
August 31 2022
End Date
May 7 2034
Last Update
July 17 2025
Active Locations (7)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229-3039
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Centre Léon Berard
Lyon, France