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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Y-mAbs Therapeutics, Inc

Criteria

Inclusion Criteria:

Inclusion Criteria for All Patients:

• Age >1 year and able to cooperate with radiation safety restrictions during therapy period.

• Minimum life expectancy of eight weeks as determined by consenting professional

• Signed informed consent indicating awareness of the investigational nature of this program

• Prior to intraperitoneal catheter placement

• At least 1 weeks must have elapsed since prior chemotherapy

• At least 2 weeks must have elapsed since prior-radiotherapy or 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:

Group A patients:

• Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK

• Have undergone GTR of radiographically evident and visible/palpable disease, as per surgeon's report

• 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

• Should not have had prior WAP IMRT

• Should not have experienced progression of disease prior to enrollment

• Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-omburtamab treatment. The minimum dose for hematopoietic stem cells is 2 x 10^6 CD34+ cells/kg

Group B patients:

• Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK

• Have radiological evidence of disease (does not need to be in the abdomen) OR

Group C patients:

• Have the diagnosis of tumors other than DSRCT, confirmed at MSK

• Have a tumor that involves the peritoneum

• Omburtamab reactivity must be confirmed by immunohistochemistry except for tumors with a reported incidence of B7H3 expression of >70%: these include neuroblastoma, melanoma, Ewing's family of tumors, rhabdomyosarcoma, osteosarcoma, Wilm's tumor, hepatoblastoma and rhabdoid tumor (testing for these histologies may be performed if desired at the discretion of the investigator and after discussion with the prinicipal investigator)

• May or may not have radiological evidence of disease

• <20% chance of long term disease-free survival

Exclusion Criteria:

• Severe major organ toxicity. Cardiac, pulmonary, and neurologic toxicity should all be grade 1 or less; Renal, gastrointestinal and hepatic, toxicities should all be grade 2 or less (per NCI CTC version 5)

• Platelet count should be >50,000/ul and hemoglobin should be >8gm/dl. Platelet transfusions are not permitted within one week for blood count demonstrating platelet count >50,000

• Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution

• History of allergy to mouse proteins

• Patients previously treated with murine monoclonal antibodies will be excluded if they have a HAMA level of >1000U/ml (defined as positive).

• Active serious infections not controlled by antibiotics

• Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

• Pregnant women and women who are breast feeding are excluded for fear of danger to the fetus/infant. Therefore, negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period and for 12 months following therapy. Pregnancy testing will be carried out within two weeks prior to administration of radioiodinated omburtamb in females of childbearing age.

• Inability or unwillingness to comply with radiation safety procedures or protocol requirements.