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Monoclonal Antibodies

Radiolabeled Antibody Therapy for Brain and Nervous System Cancers

Phase 1

Waitlist Available

Led By Kim Kramer, MD

Research Sponsored by Y-mAbs Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new radiation-based therapy for cancer using a mouse-derived antibody. The antibody will be delivered directly to the spine, and the goal is to find a safe dose that is effective at killing cancer cells.

Who is the study for?

This trial is for patients with certain advanced or recurrent cancers affecting the brain, spinal cord, or its coverings and who have not responded to standard treatments. Eligible participants must have a type of cancer that reacts to the antibody 8H9, stable neurological function, acceptable blood cell counts, and may have cancer outside the CNS. Pregnant women and those with recent radiation therapy or chemotherapy are excluded.Check my eligibility

What is being tested?

The study tests a new treatment where an antibody called 8H9 from mice is tagged with radioactive iodine (131-I) and delivered into spinal fluid to target and kill cancer cells. This first-of-its-kind approach aims to find a safe dose for this potentially innovative therapy in treating resistant brain-related cancers.See study design

What are the potential side effects?

Potential side effects might include reactions related to radiation such as nausea, fatigue, hair loss at injection site; immune responses due to foreign antibodies like fever or allergic reactions; lowered blood cell counts leading to increased infection risk; organ inflammation due to radiation exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients that have treatment related toxicities

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiolabeled Monoclonal Antibody TherapyExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterOTHER

1,933 Previous Clinical Trials

585,445 Total Patients Enrolled

70 Trials studying Sarcoma

13,590 Patients Enrolled for Sarcoma

Y-mAbs TherapeuticsLead Sponsor

25 Previous Clinical Trials

1,380 Total Patients Enrolled

2 Trials studying Sarcoma

67 Patients Enrolled for Sarcoma

Kim Kramer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

78 Total Patients Enrolled

2 Trials studying Sarcoma

78 Patients Enrolled for Sarcoma

Media Library

Iodine I 131 MOAB 8H9 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00089245 — Phase 1

Sarcoma Research Study Groups: Radiolabeled Monoclonal Antibody Therapy

Sarcoma Clinical Trial 2023: Iodine I 131 MOAB 8H9 Highlights & Side Effects. Trial Name: NCT00089245 — Phase 1

Iodine I 131 MOAB 8H9 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00089245 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any previous investigations been conducted on Iodine I 131 MOAB 8H9?

"Presently, there are 15 trials exploring the potential of Iodine I 131 MOAB 8H9. Two of them have reached Phase 3. Mostly situated in Sevilla, Vizcaya, these medical studies span across 37 different sites worldwide."

Answered by AI

Could you elucidate the safety profile of Iodine I 131 MOAB 8H9 for humans?

"The safety of Iodine I 131 MOAB 8H9 was given a score of 1 as this is an early-stage trial with limited evidence regarding efficacy and patient protection."

Answered by AI

What is the aggregate participation rate of this clinical experiment?

"Unfortunately, this trial is not currently taking new patients. It was initially posted on July 1st 2004 and most recently updated June 8th 2022. Fortunately, 665 clinical trials for neuroblastoma and 15 studies for Iodine I 131 MOAB 8H9 are actively recruiting at the moment."

Answered by AI

What conditions is Iodine I 131 MOAB 8H9 prescribed to treat?

"Iodine I 131 MOAB 8H9 is a widely utilized treatment for communicable diseases, as well as the disinfection of superficial wounds and the prevention of infection."

Answered by AI

Are there still openings available to join this investigation?

"Data on clinicaltrials.gov confirms that this particular medical trial, initially posted in July 2004 and revised most recently in June 2022, is no longer recruiting patients at the present moment. However, many other trials are currently seeking participants - 680 to be exact!"

Answered by AI

Recent research and studies

European Journal of Nuclear Medicine and Molecular ImagingJournal

Intraommaya Compartmental Radioimmunotherapy Using 131i-omburtamab—pharmacokinetic Modeling to Optimize Therapeutic Index

Yerrabelli, Rahul S., Ping He, Edward K. Fung, Kim Kramer, Pat B. Zanzonico, John L. Humm, Hongfen Guo, Neeta Pandit-Taskar, Steven M. Larson, and Nai-Kong V. Cheung. 2020. “Intraommaya Compartmental Radioimmunotherapy Using 131i-omburtamab—pharmacokinetic Modeling to Optimize Therapeutic Index”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-020-05050-z.

clinicaltrials.govStudy

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

2004. "Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00089245.