Condition or disease | Intervention/treatment | Phase |
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Desmoplastic Small Round Cell Tumor Peritoneal Cancer Peritoneal Carcinoma | Drug: 131 I-omburtamab Radiation: WA-IMRT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of 131 I-Omburtamab in Combination With External Beam Radiotherapy for Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum |
Actual Study Start Date : | July 15, 2019 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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Experimental: Group A
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 RIT plus WA-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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Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
Radiation: WA-IMRT Group A participants will receive WA-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
Other Name: Intensity Modulated Radiation Therapy
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Experimental: Group B
Participants with DSRCT without GTR
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Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
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Experimental: Group C
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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Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria for All Patients:
Prior to intraperitoneal catheter placement
At the completion of surgery, patients must fulfill all of the additional following criteria:
Group A patients:
Group B patients:
Group C patients:
Exclusion Criteria:
Contact: Emily Slotkin, MD | 212-639-8856 | slotkine@mskcc.org | |
Contact: Shakeel Modak, MD | 212-639-7623 |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Emily Slotkin, MD 212-639-8856 |
Principal Investigator: | Emily Slotkin, MD | Memorial Sloan Kettering Cancer Center |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 15, 2019 | ||||||||
First Posted Date ICMJE | July 17, 2019 | ||||||||
Last Update Posted Date | December 9, 2020 | ||||||||
Actual Study Start Date ICMJE | July 15, 2019 | ||||||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival/PFS [ Time Frame: Up to 2 years after treatment is discontinued ] Progression free survival after RIT + WA-IMRT.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum | ||||||||
Official Title ICMJE | Phase II Trial of 131 I-Omburtamab in Combination With External Beam Radiotherapy for Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum | ||||||||
Brief Summary | The purpose of this study is to determine if treatment with the investigational drug 131I-Omburtamab can prevent or delay the worsening of Desmoplastic Small Round Cell Tumors/DSRCT or other cancers of the peritoneum. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
55 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2024 | ||||||||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Inclusion Criteria for All Patients:
At the completion of surgery, patients must fulfill all of the additional following criteria: Group A patients:
Group B patients:
Group C patients:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04022213 | ||||||||
Other Study ID Numbers ICMJE | 19-182 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Collaborators ICMJE | Y-mAbs Therapeutics, Inc | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |