Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma
Conditions
Keywords
Solid Tumor, Peritoneal Solid Tumor, DSRC, I131-Omburtamab, Memorial Sloan Kettering Cancer Center, 19-182
Brief 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. 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.
Interventions
DRUG131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
RADIATIONWAP-IMRT
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
Sponsors
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival/PFS | Up to 2 years after treatment is discontinued | Progression free survival after RIT + WA-IMRT. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Slotkin, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed