Clinical Trial: Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas
Brief Summary: The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can help to control abdominal tumors in patients having surgery to remove the tumors. The safety of this drug will also be studied.
Detailed Summary:
The Study Drugs:
Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.
Surgery and Study Drug Administration:
If you are found to be eligible, the abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of abdominal surgery in more detail.
During the surgery you will receive sodium thiosulfate by vein. The abdomen will then be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated cisplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated cisplatin into the abdomen and then pulls it out and recirculates the cisplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated cisplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the cisplatin reaches all areas in the abdomen. After 90 minutes, the cisplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tumor samples will be sent to the laboratory of Dr. Dina Lev for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed be
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: Time to Relapse [ Time Frame: 1 month ]
About 1, 3, and 6 months after surgery is complete, follow-up visits and the following tests and procedures will be performed:
A CT scan, PET-CT scan, or MRI scan to check the status of the disease.
Efficacy assessed with primary endpoint of time to relapse.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: January 12, 2011
Date Started: May 9, 2011
Date Completion: May 1, 2019
Last Updated: January 26, 2017
Last Verified: January 2017
