This phase II trial studies how well 131I-omburtamab with or without external beam radiotherapy works in treating patients with desmoplastic small round cell tumors. Radioactive substances such as iodine I 131 linked to monoclonal antibody omburtamab can bind to tumor cells and give off radiation which may help kill tumor cells. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving 131I-omburtamab with external beam radiotherapy may prevent or delay the worsening of desmoplastic small round cell tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04022213.
PRIMARY OBJECTIVE:
I. Estimate progression-free survival (PFS) for desmoplastic small round cell tumor (DSRCT) patients treated with intraperitoneal (IP) radioimmunotherapy (RIT) and whole abdominopelvic intensity modulated radiotherapy (WAP IMRT) after gross total resection (GTR).
SECONDARY OBJECTIVES:
I. Estimate overall survival (OS) for DSRCT patients treated with IP RIT plus WAP IMRT after GTR.
II. Estimate abdominal PFS (defined as time from IP RIT to disease progression within the abdomen) for DSRCT patients treated with IP RIT plus WAP IMRT after GTR.
III. Evaluate the acute toxicity of IP RIT plus WAP IMRT in patients with DSRCT.
IV. Evaluate pharmacokinetics of IP RIT.
EXPLORATORY OBJECTIVE:
I. Evaluate the effect of IP RIT and WAP IMRT through cell-free circulating deoxyribonucleic acid (cfDNA) analysis.
OUTLINE:
Patients receive iodine I 131 omburtamab (131I-omburtamab) IP on day 0 and then within 14-28 days undergo WAP IMRT 5 days a week for approximately 4 weeks. Patients also undergo single photon emission computed tomography (SPECT) on approximately day 5 after receiving 131I-omburtamab. Patients undergo collection of blood samples during screening and throughout the study and collection of peritoneal fluid on study. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and throughout the study and may undergo positron emission tomography (PET).
After completion of study treatment, patients are followed up within 6 weeks and every 3-6 months for up to 5 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEmily Kanaya Slotkin