Clinical Trial: Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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

Brief Summary:

The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has.

This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: weekly ]

Original Primary Outcome: Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: twice-weekly ]

Current Secondary Outcome:

  • Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally [ Time Frame: 5 years ]
  • Assess pharmacokinetics for IP 131I-8H9 [ Time Frame: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs. ]
  • Assess response of DSRCT and other solid tumors to IP 131 I-8H9. [ Time Frame: between days 24 and 38 ]


Original Secondary Outcome:

  • Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally [ Time Frame: 5 years ]
  • Assess tumor targeting of IP 124I-8H9. [ Time Frame: between days 24 and 38 ]
  • Assess dosimetry for IP 124I-8H9. [ Time Frame: (3-5 scans over the 3 days post-124I-8H9) 1 scan at ~5 days post-131I-8H9 administration), respectively, as well as serial blood sampling ]
  • Assess biodistribution for IP 124I-8H9. [ Time Frame: Day 8: Gamma camera scan for 131I-8H9 biodistribution ]
  • Assess pharmacokinetics for IP 131I-8H9 [ Time Frame: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs. ]
  • Assess response of DSRCT and other solid tumors to IP 131 I-8H9. [ Time Frame: between days 24 and 38 ]


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: April 6, 2010
Date Started: April 2010
Date Completion: April 2018
Last Updated: May 2, 2017
Last Verified: May 2017