Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
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|ClinicalTrials.gov Identifier: NCT01099644|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2010
Last Update Posted : May 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Cancer||Biological: 131 I-8H9||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||September 2020|
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.
- Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: weekly ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099644
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Shakeel Modak, MD||Memorial Sloan Kettering Cancer Center|