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

Study Overview
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Brief Summary
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The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.

Official Title
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Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor

Conditions
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Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma

Intervention / Treatment
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* Drug: 131 I-omburtamab
* Radiation: WAP-IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have the diagnosis of DSRCT confirmed at MSKCC Age >1 year and able to cooperate with radiation safety restrictions during therapy period. Prior to intraperitoneal catheter placement At least 1 weeks must have elapsed since prior chemotherapy At least 2 weeks must have elapsed since biologic therapy Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline At the completion of surgery, patients must fulfill all of the additional following criteria: 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 Exclusion Criteria: Prior progression of disease Prior hypothermic intraperitoneal chemotherapy (HIPEC) Cardiac, pulmonary, and neurologic toxicity should be grade 1 or less per NCI CTC version 5 Renal, gastrointestinal, and hepatic, toxicities should all be grade 2 of less (per NCI CTC version 5) History of allergy to mouse proteins Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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. | Drug: 131 I-omburtamab<br>* Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2<br>Radiation: WAP-IMRT<br>* Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks<br>* Other names: Intensity Modulated Radiation Therapy;|
| Experimental: Group B<br>DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR | Drug: 131 I-omburtamab<br>* Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2<br>|
| Experimental: Group C<br>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). | Drug: 131 I-omburtamab<br>* Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival/PFS | Progression free survival after RIT + WA-IMRT. | Up to 2 years after treatment is discontinued | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumor, Peritoneal Solid Tumor, DSRC, I131-Omburtamab, Memorial Sloan Kettering Cancer Center, 19-182