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| Name | Class |
|---|---|
| Y-mAbs Therapeutics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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. |
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| Group B | Experimental | DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR |
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| Group C | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 131 I-omburtamab | Drug | Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival/PFS | Progression free survival after RIT + WA-IMRT. | Up to 2 years after treatment is discontinued |
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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 the completion of surgery, patients must fulfill all of the additional following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Slotkin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| WAP-IMRT | Radiation | 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 |
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| ID | Term |
|---|---|
| D058405 | Desmoplastic Small Round Cell Tumor |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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