177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma
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|ClinicalTrials.gov Identifier: NCT04167618|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medulloblastoma, Childhood||Drug: 177Lu-DTPA-omburtamab||Phase 1 Phase 2|
Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab.
Part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177Lu-DTPA-omburtamab at the recommended dose determined in Part 1.
End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up to 2 years after last dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will receive up to two cycles in Part 1 and up to five cycles in Part 2 of intracerebroventricular 177Lu-DTPA-omburtamab. Safety and efficacy will be investigated during treatment and follow-up period.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose-escalation and Expansion Cohort Trial of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-Omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory Medulloblastoma|
|Estimated Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||October 15, 2024|
|Estimated Study Completion Date :||October 15, 2024|
Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to two cycles (Part 1) and up to five cycles (Part 2).
Biological, radiolabeled DPTA-omburtamab
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 1 year ]Safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE version 5.0. The maximum tolerated dose and the recommended phase 2 dose (RP2D) will be determined in Part 1
- Incidence of AEs and SAEs [ Time Frame: 2 years ]In Part 2, safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE version 5.0, at the RP2D defined in Part 1
- Analysis of lutetium-177 activity in blood [ Time Frame: 2 weeks ]The time for maximum absorbed radiation dose
- Analysis of lutetium-177 activity in blood [ Time Frame: 2 weeks ]Elimination half-life of radioactivity
- Absorbed radiation dose of lutetium-177 in blood and cerebrospinal fluid (CSF) [ Time Frame: 2 weeks ]Time-activity curves of radioactivity measurements in blood and CSF will be modeled to deliver absorbed doses in blood and CSF
- Dosimetry analysis of lutetium-177 [ Time Frame: 2 weeks ]Whole-body dosimetry by gamma camera scans and single-photon emission computed tomography (SPECT)
- Maximum Plasma Concentration [Cmax] in CSF [ Time Frame: 7 weeks ]Concentration of 177Lu-DTPA-omburtamab in CSF
- Maximum Plasma Concentration [Cmax] in serum [ Time Frame: 7 weeks ]Concentration of 177Lu-DTPA-omburtamab in serum
- Elimination Half Life in CSF [ Time Frame: 7 weeks ]Concentration of 177Lu-DTPA-omburtamab in CSF
- Elimination Half Life in serum [ Time Frame: 7 weeks ]Concentration of 177Lu-DTPA-omburtamab in serum
- Response [ Time Frame: 2 years ]Objective Response Rate (ORR) is defined as partial response (PR) or complete response (CR) and as defined by the Response Assessment in Pediatric Neuro Oncology (RAPNO) criteria (as determined from magnetic resonance imaging [MRI] assessments), neurological examination, and cerebrospinal fluid (CSF) cytology
- Investigator-assessed duration of response (DoR) [ Time Frame: 2 years ]DoR is defined as the time from response (CR or PR) to progression
- Progression Free Survival (PFS) [ Time Frame: 2 years ]PFS is defined as the time from the first treatment to date of progression or death from any cause, whichever comes first
- Overall Survival (OS) [ Time Frame: 2 years ]OS is defined as the time from first treatment until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04167618
|Contact: Joris Wilmsfirstname.lastname@example.org|