177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-08-11

Brief Summary

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Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

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Detailed Description

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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.

Conditions

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Medulloblastoma, Childhood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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177Lu-DTPA-omburtamab

Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to two cycles (Part 1) and up to five cycles (Part 2).

Group Type EXPERIMENTAL

177Lu-DTPA-omburtamab

Intervention Type DRUG

Biological, radiolabeled DPTA-omburtamab

Interventions

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177Lu-DTPA-omburtamab

Biological, radiolabeled DPTA-omburtamab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of medulloblastoma.
* SHH, Group 3, or Group 4 according to World Health Organisation (WHO) 2016 classification.
* Recurrent (maximum of 2 recurrences for Part 1 and 1 recurrence for Part 2) or refractory to frontline therapy. Prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.
* Have refractory disease, focal or multifocal recurrent disease, or pure leptomeningeal disease. Cytological or radiographic remission is allowed; however, not simultaneously.
* Performance status score of 50 to 100 on Lansky (less than 16 years) or Karnofsky (16 years or older) scales.
* Life expectancy of at least 3 months, as judged by the Investigator.
* Acceptable hematological status and liver and kidney function.

Exclusion Criteria

* Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/cerebrospinal fluid (CSF) flow study.
* Residual disease (nodular or linear) measuring \> 15 mm in the smallest diameter.
* Ventriculoperitoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.
* Grade 4 nervous system disorder. Stable neurological deficits (due to brain tumor or surgery) or hearing loss are allowed.
* Uncontrolled life-threatening infection.
* Received radiation therapy less than 3 weeks prior to the screening visit.
* Received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit.
* Received any prior anti-B7-H3 treatment.
* Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.
* Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.

Minimum Eligible Age

3 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No