Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Assess response of DSRCT and other solid tumors to IP 131 I-8H9. [ Time Frame: between days 24 and 38 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: 131 I-8H9
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
Biological: 131 I-8H9
Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099644
|Contact: Shakeel Modak, MD||212-639-7623|
|Contact: Nai-Kong Cheung, M.D., Ph.D.||646-888-2313|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Shakeel Modak, MD 212-639-7623|
|Principal Investigator:||Shakeel Modak, MD||Memorial Sloan Kettering Cancer Center|