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
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
-
Memorial Sloan Kettering Cancer Center
collaborator OTHER -
Y-mAbs Therapeutics
lead INDUSTRY
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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