Desmoplastic Small Round Cell TumorPhase 2NCT04022213
A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
A Phase 2 study testing 131 I-omburtamab and WAP-IMRT in people with Desmoplastic Small Round Cell Tumor and Peritoneal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma
- What is being tested?
- 131 I-omburtamab and WAP-IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior progression of disease
- Prior hypothermic intraperitoneal chemotherapy (HIPEC)
- Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5
- Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5)
- History of allergy to mouse proteins
- Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor
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.
- Being tested
- 131 I-omburtamab, WAP-IMRT
- Keywords
- Solid Tumor, Peritoneal Solid Tumor, DSRC, I131-Omburtamab, Memorial Sloan Kettering Cancer Center, 19-182
- Medical subject headings
- Desmoplastic Small Round Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131 I-omburtamabDrug
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
WAP-IMRTRadiation
Also called Intensity Modulated Radiation Therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 131 I-omburtamab; Radiation: WAP-IMRT |
| 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 Receives: Drug: 131 I-omburtamab |
| 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). Receives: Drug: 131 I-omburtamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival/PFS
Progression free survival after RIT + WA-IMRT.
Measured: Up to 2 years after treatment is discontinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start15 Jul 2019
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoplastic Small Round Cell TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Y-mAbs Therapeutics
- Responsible party
- Sponsor
- Investigators
- Emily Slotkin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022213
- Sponsor's protocol ID
- 19-182
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2019
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.