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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
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterOTHER
1,940 Previous Clinical Trials
588,734 Total Patients Enrolled
70 Trials studying Sarcoma
13,585 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a confirmed diagnosis of a specific type of cancer, and your tumor tests positive for a certain protein called 8H9.You have a condition called hydrocephalus that is causing symptoms or blockages.You have received chemotherapy (excluding corticosteroids) within the last 3 weeks before the trial starts.Your kidneys, heart, liver, lungs, and digestive system should not have severe damage. If you have stable brain-related issues or mild hearing loss, you are not excluded.You have brain or spinal cord disease that has not improved with standard treatments, or you have a specific type of recurrent brain tumor.You should not have rapidly worsening or declining neurological symptoms.Your blood must have enough white blood cells and platelets.You have cancer in parts of your body other than the brain or spinal cord.People of any age, including kids and adults, can participate.Patients with stored stem cells will receive a different treatment dose than patients without stored stem cells. Neuroblastoma patients can receive a specific treatment dose regardless of stored stem cells.
Research Study Groups:
This trial has the following groups:- Group 1: Radiolabeled Monoclonal Antibody Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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