RECRUITING

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)

Official Title

Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET

Quick Facts

Study Start:2022-11-21
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05278208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amy Jones, MSN
CONTACT
614-722-8566
amyknappjones@outlook.com

Principal Investigator

Margot Lazow
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43235
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Margot Lazow, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-21
Study Completion Date2027-11

Study Record Updates

Study Start Date2022-11-21
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Somatostatin Receptor
  • DOTATATE
  • Lutathera

Additional Relevant MeSH Terms

  • High Grade Glioma
  • Meningioma
  • Embryonal Tumor
  • Medulloblastoma
  • Anaplastic Ependymoma
  • Recurrent Diffuse Intrinsic Pontine Glioma
  • Recurrent Malignant Glioma
  • Recurrent Medulloblastoma
  • Recurrent Primary Central Nervous System Neoplasm
  • Refractory Diffuse Intrinsic Pontine Glioma
  • Refractory Malignant Glioma
  • Refractory Medulloblastoma
  • Refractory Primary Central Nervous System Neoplasm