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Cisplatin

HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions. Cisplatin 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the Cisplatin.

HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions.

Hyperthermic Peritoneal Perfusion (HIPEC)

100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.

Andrea Hayes-Jordan, MD

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.

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 before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment. The samples will be destroyed after these tests are complete.

There is a chance that 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.

Study Visits:

On Days 1-5, 11, and 14, (Day 1 being the day after surgery):

* Blood (about 1 teaspoon) will be drawn for routine tests.
* You will have a physical exam, including measurement of your weight and vital signs.

Follow-Up Visits:

About 1, 3, and 6 months after the surgery is complete, you will have follow-up visits and the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight and vital signs.
* Blood (about 1 teaspoon) will be drawn at the 1 month visit only for routine tests.
* You will have a hearing test at the 1 month visit only.
* Blood (about 3 teaspoons) will be drawn for routine tests at the 3 and 6 month visits only.
* At the 3 and 6 month visits only, you will have a CT scan, positron emission tomography (PET)-CT scan, or MRI scan to check the status of the disease.

Length of Study:

You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.

If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible for a re-perfusion, which is a repeat of the operation and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.

This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of cisplatin in patients with abdominal sarcoma-type tumors is investigational.

Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.

Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor

A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas

Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence

From the date of diagnosis to the date of death or last follow up date for patient alive.

M.D. Anderson Cancer Center

HIPEC

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Russia

Region of Enrollment

Andrea Hayes-Jordan M.D. / Surgical Oncology

Recurrence Free Survival

Overall Survival

Overall Study

Pelvic Neoplasms

Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention

Thomas BLANC, MD

Gael PLASTOW

Sabine SARNACKI, MD

This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.

The investigator will inform the child and his parents during the pre-surgical consultation, and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan. Patients requiring emergency imaging will not be included.

Pelvic tumors will benefit from MRI imaging and renal tumors from MRI and/or CT scan.

A CT scan will be carried out for retroperitoneal tumors other than renal tumors (mainly neuroblastomas).

All of the above examinations are carried out as part of the usual treatment, in the month preceding the surgery.

Pre-operatively After the imaging has been carried out, the 2D images will be presented to the patient and his family before surgery as it is done routinely. The 3D image will be showed afterwards. The family will have the opportunity to ask questions which the surgeon will answer as usually done.

The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team.

Once the patient is included and the examinations have been carried out, the operating surgeons and their assistants (help No. 1 and 2) will look at the 2D images, followed by the 3D images secondly a few days before surgery. They will complete the specific questionnaire and give it to the research team.

Once the patient is included and the imaging examinations have been carried out, surgeons external to the service will be contacted by the research team to organize a remote review session. The 2D images will be presented to them first, followed by the 3D images on the visualization software, via a remote communication system with screen sharing. They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post.

Intraoperatively:

The 3D model of the patient will be displayed in the operating room, and/or integrated into the robot's display console (for robot-assisted surgeries) during the surgical procedure. At the end of the surgery, the operating surgeon and his assistants will complete (independently) a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model.

Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging

Comparison of the automatically segmented 3D model to the reference manual segmentation

Distance comparison between the reference segmentation and the one obtained by the algorithm

Recognition of anatomical structures comparison from 2D imaging and 3D imaging by surgeons preoperatively

Contribution of 3D modeling comparison to 2D imaging in pre-operative planning

Added value evaluation of 3D modelling compared to 2D imaging for surgeons pre-operatively

Surgeons' support evaluation for integrating 3D modelling into routine pre-operative planning

Evaluation of the contribution of 2D imaging for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively

Contribution of 3D modelling evaluation compared to 2D imaging for surgeons during surgery

Consistency evaluation of the 3D imaging with anatomy observed intraoperatively

Surgeons' support evaluation for integrating 3D modeling into their current practice

Imagine Institute

Assistance Publique - Hôpitaux de Paris

Gland and Hormone Related Diseases

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Genital Diseases

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Peritoneal Diseases

Ovarian Cancer

Neuroepithelioma

Abdominal Surgery + CHPP of Escalating Cisplatin (Starting dose of 100 mg/m\^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.)

Starting dose of 100 mg/m\^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.

CHPP of Cisplatin

Abdominal Surgery

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)

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 M.D. 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.

Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer

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

The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor	NCT01277744	Advanced Cancer... Sarcoma	Hyperthermic Pe... Cisplatin	1 Year -	M.D. Anderson Cancer Center
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors	NCT06418243	Pelvic Tumor Retroperitoneal...		3 Months - 17 Years	Assistance Publique - Hôpitaux de Paris
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors	NCT06418243	Pelvic Tumor Retroperitoneal...		3 Months - 17 Years	Assistance Publique - Hôpitaux de Paris
Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor	NCT01277744	Advanced Cancer... Sarcoma	Hyperthermic Pe... Cisplatin	1 Year -	M.D. Anderson Cancer Center
Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer	NCT00436657	Peritoneal Neop... Retroperitoneal... Gastrointestina... Adenocarcinoma Neuroblastoma Ovarian Neoplas... Sarcoma Adrenocortical ... Wilms Tumor Rhabdomyosarcom... Desmoplastic Sm...	CHPP of Cisplat... Abdominal Surge...	3 Years - 18 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for retroperitoneal tumor