Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Histiocytoma, Malignant Fibrous

Hemangioendothelioma

Sarcoma, Synovial

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Hemangioma

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Epithelioid Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Trabectedin

Antineoplastic Agents, Alkylating

Alkylating Agents

This study is a single arm study with biomarker analysis

- Trabectedin will be prescribed as per market authorization and will be administered by intraveinous infusion (1,5 mg/m²) every 3 weeks. A treatment cycle is defined as a 3-weeks period

Antoine ITALIANO, MD, PhD

Simone MATHOULIN-PELISSIER, MD, PhD

Antoine ITALIANO

This is a biology driven, monocentric study, designed to identify biomarkers of activity of trabectedin in patients with advanced non-L soft-tissue sarcoma. The aim of this study is to implement high-throughput profiling technologies to identify predictive biomarkers of trabectedin efficacy through sequential tumor biopsies and blood sample collection in sarcoma patients.

The identification of predictive biomarkers of the clinical benefit of trabectedin is a crucial issue to identify potential responders particularly for non-L sarcomas. Considering that the molecular profile of STS can change over time, an analysis of archival tumor material may not be a reliable method to identify predictive biomarkers of response, and thus high-throughput technologies may be promising to identify STS markers for prediction of response to trabectedin. For study purpose, blood and tumor samples will be obtained for genetic and immunological profiling at baseline, during treatment by trabectedin and at disease progression.

Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

Efficacy of trabectedin is defined as objective response \[OR\] or stable disease \[SD\] \> 6 months. Absence of efficacy is defined as progressive disease \[PD\] within 2 months.

Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

Institut Bergonié

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Hyperthermia

Gastrointestinal Neoplasms

Fever

Wilms Tumor

Neuroblastoma

Peritoneal Neoplasms

Digestive System Neoplasms

Adrenocortical Carcinoma

Rhabdomyosarcoma

Desmoplastic Small Round Cell Tumor

Retroperitoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Myosarcoma

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Abdominal Neoplasms

Peritoneal Diseases

Ovarian Cancer

Wilms' Tumor

Neuroepithelioma

Cisplatin

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

Andrea Hayes-Jordan, MD

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).

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients	NCT04008238	Soft Tissue Sar... Undifferentiate... Epithelioid Sar... Solitary Fibrou... Hemangioendothe... Desmoplastic Ro... Synovial Sarcom...	Trabectedin	18 Years -	Institut Bergonié
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 desmoplastic round cell tumor