Suspended

Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms

What is being tested

Iodine I 131 MOAB 8H9

Drug

Who is being recruted

Brain Diseases+29

+ Brain Neoplasms

+ Central Nervous System Diseases

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2004

See protocol details

Summary

Principal SponsorY-mAbs Therapeutics

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 5, 2004

Actual date on which the first participant was enrolled.

This is a phase I study, where the purpose is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.

Official TitlePhase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms

NCT00089245

Principal SponsorY-mAbs Therapeutics

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

177 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesGliomaMedulloblastomaMeningeal NeoplasmsMyosarcomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Muscle TissueNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroblastomaRhabdomyosarcomaSarcomaOsteosarcomaCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, Complex and MixedNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialRhabdoid TumorMeningeal CarcinomatosisDesmoplastic Small Round Cell Tumor

Criteria

6 exclusion criteria prevent from participating

Patients with obstructive or symptomatic communicating hydrocephalus.

Patients with an uncontrolled life-threatening infection.

Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.

Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

This is a Phase I trial designed to evaluate the Maximally Tolerated Dose (MTD) of intrathecal 131I-8H9. In order to find the MTD, a dose escalation scheme will be employed with patients entering in cohorts of 3 at each dose level from 10 mCi to 60 mCi and a cohort of 6 at each dose level from 70 mCi to 100 mCi.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan Kettering Cancer Center

New York, United StatesOpen Memorial Sloan Kettering Cancer Center in Google Maps

SuspendedOne Study Center