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Radioactive Drug

I131-Omburtamab for Peritoneal Cancer

Phase 2

Recruiting

Led By Emily Slotkin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

- Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-omburtamab treatment. The minimum dose for hematopoietic stem cells is 2 x 10^6 CD34+ cells/kg

- Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after treatment is discontinued

Awards & highlights

Study Summary

This trial is testing the effects of 131I-omburtamab, which may help prevent cancer from returning or spreading, but may also cause side effects. Researchers want to learn more about how the drug works in the body and how effective it is in treating cancer.

Who is the study for?

This trial is for people with a rare cancer called Desmoplastic Small Round Cell Tumor (DSRCT) or other cancers in the lining of the abdomen. Participants must not have active liver disease or disease outside the abdomen, be over 1 year old, and able to follow safety rules during treatment. They should not have had certain treatments recently and must meet specific health criteria including organ function.Check my eligibility

What is being tested?

The study tests I131-Omburtamab's effects on preventing or delaying cancer return in DSRCT and peritoneal cancers. It's an investigational drug, meaning it isn't FDA-approved yet for these conditions. The trial also includes Whole Abdomen Intensity-Modulated Radiotherapy (WAP-IMRT), which is a precise radiation therapy technique.See study design

What are the potential side effects?

Possible side effects of I131-Omburtamab may include allergic reactions due to mouse proteins, major organ toxicity affecting heart, lungs, nerves among others at varying degrees of severity; blood count issues like low platelets or hemoglobin; infections uncontrolled by antibiotics; hypersensitivity to iodine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have my stem cells stored for treatment after 131 I-omburtamab.

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I don't have active cancer in my liver or beyond my abdomen, or it was fully removed.

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I have not had WAP IMRT treatment before.

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My cancer has spread to the lining of my abdomen.

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I had surgery to remove all visible signs of my disease, according to my surgeon.

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My tumor diagnosis, confirmed at MSK, is not DSRCT.

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My DSRCT diagnosis with peritoneal involvement was confirmed at MSK.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after treatment is discontinued

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after treatment is discontinued

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after treatment is discontinued for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression Free Survival/PFS

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment1 Intervention

Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded).

Group II: Group BExperimental Treatment1 Intervention

DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR

Group III: Group AExperimental Treatment2 Interventions

Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently <500/ul despite use of G-CSF for >1 week, or if patients experience life threatening febrile neutropenia.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,502 Total Patients Enrolled

1 Trials studying Desmoplastic Small Round Cell Tumor

54 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Y-mAbs Therapeutics, IncUNKNOWN

3 Previous Clinical Trials

436 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,843 Total Patients Enrolled

4 Trials studying Desmoplastic Small Round Cell Tumor

310 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Media Library

131 I-omburtamab (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04022213 — Phase 2

Desmoplastic Small Round Cell Tumor Research Study Groups: Group A, Group C, Group B

Desmoplastic Small Round Cell Tumor Clinical Trial 2023: 131 I-omburtamab Highlights & Side Effects. Trial Name: NCT04022213 — Phase 2

131 I-omburtamab (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04022213 — Phase 2

Frequently Asked Questions

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

Is enrollment for this experiment still open?

"The clinical trial is actively recruiting, according to the information found on clinicaltrials.gov. This medical study was first posted on July 15th 2019 and recently modified on November 14th 2022."

Answered by AI

How many participants have been enrolled in this research endeavor?

"Correct. According to the clinicaltrials.gov records, this medical experiment is actively recruiting patients as of November 14th 2022; it was initially advertised on July 15th 2019. The study requires 55 participants from a single site for enrollment."

Answered by AI

Is this research novel or has it been conducted before?

"Presently, 8 cities and 7 countries are hosting 3 different 131 I-omburtamab trials. Y-mAbs Therapeutics' first of these studies began in 2018; it included 50 participants and progressed through Phase 2 & 3 of its drug approval process. Since then, there has been one additional live trial for the medication."

Answered by AI

What deleterious effects might 131 I-omburtamab have on patients?

"131 I-omburtamab is presumed to be safe based on existing Phase 2 trials; therefore, it was assigned a score of 2. Nevertheless, there remains no clinical evidence in support of its efficacy."

Answered by AI

Could you provide an overview of the other experiments conducted to assess 131 I-omburtamab?

"Currently, there are three clinical trials studying 131 I-omburtamab with one of them in the advanced Phase 3 stage. Most studies for this medication take place in Columbus, Ohio but other sites across the US have also been included to broaden participant recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

2019. "A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04022213.

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