A Phase I Study of Intraperitoneal Radioimmunotherapy with 131I-8H9 for Patients with Desmoplastic Small Round Cell Tumors and Other Solid Peritoneal Tumors

Protocol
09-090
Full Title
Phase I Study of Intraperitoneal Radioimmunotherapy with 131I-8H9 for Patients with Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Phase
I
Purpose

The purpose of this study is to evaluate the safety of different dose levels of the radiolabelled antibody 8H9 injected into the lining of the abdomen or peritoneum to treat patients with desmoplastic small round cell tumors (DSCRT) or other solid peritoneal tumors. This medicine is an antibody which binds to certain tumors, including DSCRT. Radioactive iodine is bound to 8H9 to deliver radiation directly to the tumor to kill tumor cells.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have DSCRT or another peritoneal solid tumor to which the 8H9 antibody will bind.
  • For patients with tumors other than DSCRT, the tumor must have progressed or recurred despite prior standard therapy.
  • At least 3 weeks must have passed since completion of prior chemotherapy or radiation therapy and 4 weeks since biological therapy or immunotherapy and entry into the study.
  • Patients must be older than age 1.

For more information about this study and to inquire about eligibility, please contact Dr. Shakeel Modak at 212-639-7623.

Locations