Clinical Trials / Research Studies
Clinical Trials / Research Studies

CAAA601A32201: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

Why are we doing this research?

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. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.

CAAA601A32201: A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL).

Who can participate?

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Ages

12 Years to 17 Years

Conditions

  • Solid Tumors - All Other

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org