Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

NCT00089245 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2023-12-26

No results posted yet for this study

Summary

The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous system/leptomeningeal (CNS/LM) malignancies.

Conditions

Interventions

DRUG

Iodine I 131 MOAB 8H9

Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.

DRUG

Iodine I 131 MOAB 8H9

The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.

Sponsors & Collaborators

Principal Investigators

  • Kim Kramer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-05
Primary Completion
2022-02-02
Completion
2022-02-02

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00089245 on ClinicalTrials.gov