A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Desmoplastic Small Round Cell Tumor; Peritoneal Cancer; Peritoneal Carcinoma

Treatments: Radiation: WAP-IMRT; Drug: 131 I-omburtamab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04022213

19-182

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Drug: 131 I-omburtamab

Radiation: WAP-IMRT

Group B

Experimental group

Description:

DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR

Treatment:

Drug: 131 I-omburtamab

Group C

Experimental group

Description:

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).

Treatment:

Drug: 131 I-omburtamab