Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436657
Status:
COMPLETED
Last Update Posted:
2012-04-02
First Post:
2007-02-15
Brief Title:
Continuous Hyperthermic Peritoneal Perfusion CHPP With Cisplatin for Children With Peritoneal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion CHPP With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis in childhood tumors Once this advanced stage of disease is evident survival is measured in weeks The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in adult clinical trials using continuous hyperthermic peritoneal perfusion CHPP for advanced peritoneal adenocarcinoma of gastrointestinal origin ovarian carcinoma and mesothelioma
This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the abdominal cavity If tumors are outside the abdominal cavity the tumors must be able to be controlled
Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases this study will evaluate the safety of elevated temperature 40oC with intraperitoneal cisplatin chemotherapy
Primary Objectives
1 To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors
2 To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
3 To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion Optional
This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the abdominal cavity If tumors are outside the abdominal cavity the tumors must be able to be controlled
Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases this study will evaluate the safety of elevated temperature 40oC with intraperitoneal cisplatin chemotherapy
Primary Objectives
1 To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors
2 To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
3 To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion Optional
Detailed Description:
Cisplatin has an atom at its center that contains platinum The platinum is supposed to poison the cancer cells causing them to eventually die Sodium thiosulfate is designed to bind-up any Cisplatin that has escaped from the abdomen into the blood stream
This is an investigational treatment which has been performed on two children on a compassionate use basis in North America Both surgeries were performed at MD Anderson by the Study Chairman
Before you can start receiving the study drugs you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study A physical exam will be performed and you will have a computed tomography CT scan or magnetic resonance imaging MRI scan to make sure the disease is only in the abdomen stomach area Blood about 1 teaspoon will be drawn for routine tests You may have an echocardiogram ECHO--a test to check heart function and electrocardiogram ECG--a test to measure electrical activity of the heart if you have ever taken an anthracycline drug An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size Women who are able to have children must have a negative urine pregnancy test
If you are found to be eligible you will have a hearing test before your surgery and at your one-month evaluation
If you are found to be eligible the abdominal surgery will be performed to try to remove as many tumors as possible The surgeon may decide during the surgery that the abdominal wash will not be performed for example if the disease has spread to or attached to certain organs If this occurs your doctor will discuss other treatment options with you
If the doctor decides that you are eligible to receive the abdominal wash a drug called sodium thiosulfate will be given through a needle in your vein The abdomen will then be temporarily closed Then the abdominal wash will begin This will be done in the same room while you are under anesthesia During the abdominal wash the heated cisplatin will be given into your abdomen and will wash over the area of the surgical procedure There will be a pump attached to the plastic tubing and that will pump the drug in and out of your abdomen during that 90 minute period while the surgeon is gently compressing your abdominal wall so that the drug can reach all areas of your abdomen equally After 90 minutes the drug is removed and your abdomen is washed with saline Then all the fluid is removed and the surgeon permanently closes your abdomen with 3 layers of stitches
The actual dose level of cisplatin that you will receive will be decided when you enter the study Participants on this study will be enrolled in groups of 3 and each group will be given a specific dose level of cisplatin The first group will receive the lowest dose of cisplatin If there are no severe or life-threatening side effects in this first group of patients the next group will receive a higher dose of cisplatin and so on This process of increasing the dose level for each new group of participants will continue until some patients have severe or life-threatening side effects At that point the dose level of cisplatin will be lowered and tested again in more participants
Blood about 1 teaspoon will be drawn for routine tests This testing will take place during the operation and every day until you leave the hospital
After you leave the hospital you will have a study visit about 1 month later and then every 3 months for 6 months At these visits you will have a CT scan or MRI scan and a physical exam to check the status of the disease
You will be taken off study if the disease gets worse or if you are disease free at or after your 6 month follow-up
This is an investigational study Cisplatin is FDA-approved and commercially available Up to 18 patients will take part in this study All will be enrolled at M D Anderson
This is an investigational treatment which has been performed on two children on a compassionate use basis in North America Both surgeries were performed at MD Anderson by the Study Chairman
Before you can start receiving the study drugs you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study A physical exam will be performed and you will have a computed tomography CT scan or magnetic resonance imaging MRI scan to make sure the disease is only in the abdomen stomach area Blood about 1 teaspoon will be drawn for routine tests You may have an echocardiogram ECHO--a test to check heart function and electrocardiogram ECG--a test to measure electrical activity of the heart if you have ever taken an anthracycline drug An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size Women who are able to have children must have a negative urine pregnancy test
If you are found to be eligible you will have a hearing test before your surgery and at your one-month evaluation
If you are found to be eligible the abdominal surgery will be performed to try to remove as many tumors as possible The surgeon may decide during the surgery that the abdominal wash will not be performed for example if the disease has spread to or attached to certain organs If this occurs your doctor will discuss other treatment options with you
If the doctor decides that you are eligible to receive the abdominal wash a drug called sodium thiosulfate will be given through a needle in your vein The abdomen will then be temporarily closed Then the abdominal wash will begin This will be done in the same room while you are under anesthesia During the abdominal wash the heated cisplatin will be given into your abdomen and will wash over the area of the surgical procedure There will be a pump attached to the plastic tubing and that will pump the drug in and out of your abdomen during that 90 minute period while the surgeon is gently compressing your abdominal wall so that the drug can reach all areas of your abdomen equally After 90 minutes the drug is removed and your abdomen is washed with saline Then all the fluid is removed and the surgeon permanently closes your abdomen with 3 layers of stitches
The actual dose level of cisplatin that you will receive will be decided when you enter the study Participants on this study will be enrolled in groups of 3 and each group will be given a specific dose level of cisplatin The first group will receive the lowest dose of cisplatin If there are no severe or life-threatening side effects in this first group of patients the next group will receive a higher dose of cisplatin and so on This process of increasing the dose level for each new group of participants will continue until some patients have severe or life-threatening side effects At that point the dose level of cisplatin will be lowered and tested again in more participants
Blood about 1 teaspoon will be drawn for routine tests This testing will take place during the operation and every day until you leave the hospital
After you leave the hospital you will have a study visit about 1 month later and then every 3 months for 6 months At these visits you will have a CT scan or MRI scan and a physical exam to check the status of the disease
You will be taken off study if the disease gets worse or if you are disease free at or after your 6 month follow-up
This is an investigational study Cisplatin is FDA-approved and commercially available Up to 18 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None