A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07698899
Phase
PHASE1
Status
Recruiting
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Conditions

  • CNS Metastases
  • Central Nervous System Metastasis
  • Recurrent Medulloblastoma
  • Refractory Medulloblastoma

Eligibility Criteria

Sex
ALL
Age
3 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • 25 mCi 177Lu- DTPA-omburtamab — BIOLOGICAL
    The dose of DTPA-omburtamab will be decided by the dose escalation design

Study Details

The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Jun 2, 2030
Completion
Jul 2, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1: 25 mCi
    25 mCi 177Lu- DTPA-omburtamab
  • Experimental: Dose Level 2: 50 mCi
    50 mCi 177Lu- DTPA-omburtamab
  • Experimental: Dose Level 3: 75 mCi
    75 mCi 177Lu- DTPA-omburtamab
  • Experimental: Dose Level 4: 100 mCi
    100 mCi 177Lu- DTPA-omburtamab

Primary Outcome Measure

Number of participants with toxicities [ Time Frame: Up to 2 cycles (each cycle is 28 days) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Sameer Farouk Sait, MBBS
212-639-2153
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Sameer Farouk Sait, MBBS
212-639-2153
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Sameer Farouk Sait, MBBS
212-639-2153
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Sameer Farouk Sait, MBBS
212-639-2153
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)HarrisonNew York10604
Sameer Farouk Sait, MBBS
212-639-2153
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Sameer Farouk Sait, MD
212-639-2153
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)UniondaleNew York11553
Sameer Farouk Sait, MBBS
212-639-2153

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering at Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering at Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering at Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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