Clinical Trial · NCT01099644

Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum

Overview

A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients \>1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.

Sponsor

Y-mAbs Therapeutics, Inc.

Phase

Phase 1

Contacts

Shakeel Modak, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01099644

Drug / Compound

omburtamab

Isotope(s):

Target(s):

B7H3

Ligand Class: Antibodies

Eligibility

Inclusion

Patients with tumors other than DSRCT without measurable or evaluable disease will only be considered if they have \<20% chance of long term disease-free survival.
Patients with DSCRT are not required to have measurable or evaluable disease.
For tumors other than DSRCT, Burtomab reactivity must be confirmed by immunohistochemistry.
For tumors other than DSRCT, patients must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy or \<20% chance of long term disease-free survival.

Exclusion

Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 1 or less (per NCI CTC version 3 criteria) with the following exceptions: serum AST,ALT and alkaline phosphatase should be ≤5 x upper limit of normal (ULN), serum bilirubin ≤ 3 x ULN and nausea and vomiting should be ≤ grade 2 Patients with myelosuppression are not excluded if ANC ≥ 500/uL.
Active serious infections not controlled by antibiotics.
Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution.
Platelet count should be \> 50,000/ul and hemoglobin should be \> 8gm/dl. Patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels.
Patients previously treated with murine monoclonal antibodies will be excluded if they have a HAMA level of \>1000U/ml.