Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

Lung Cancer Clinical Trial

Official title: A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.

Clinical Trial Description

Surgery and Study Drug Administration:

If you are found to be eligible to take part in this study, chest surgery will be performed to try to remove as many tumors as possible. The chest surgery is not being performed specifically for this research study and would be performed as part of your standard of care treatment 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 chest surgery in more detail.

During the chest surgery, you will receive amifostine by vein to help prevent possible side effects, such as ear and/or kidney damage. The chest will then be closed with a plastic tube left in place. Then, the chest wash will begin. During the chest wash, a pump that is connected to the plastic tube pushes the heated cisplatin into the chest and then pulls it out to recirculate the cisplatin. The surgeon will also wash over the closed area of the surgical site with heated cisplatin. The heated cisplatin will be recirculated in and out of the chest over 60 minutes while the surgeon gently presses on the chest wall to help the cisplatin reach all areas in the chest. The plastic tube the heated cisplatin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if you did not agree to take part in this study.

During the surgery, extra blood (about ½ teaspoon each time) and fluid from the chest area will be collected for pharmacokinetic (PK) testing when you begin to receive the first infusion of the heated cisplatin, then 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin. The blood and fluid from the chest area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.

There is a chance that the surgeon may decide during the surgery that the chest 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 after the surgery is complete.

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.

Follow-Up Visits:

About 1 month after the surgery is complete, you will have a follow-up visit and the following tests and procedures will be performed:

• You will have a physical exam.

• Blood (about 1-3 teaspoons) will be drawn for routine tests.

• You will have a hearing test at the 1 month visit only.

It is recommended that you have follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons), you will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at your local doctor's office and/or laboratory.

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 to have the operation with heated cisplatin wash repeated. If you are eligible for to have the surgery repeated, your active 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 a heated cisplatin wash during chest surgery in patients with lung tumors is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Lung Cancer
• Neoplasms

• NCT number: NCT01998529
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2014
• Completion date: August 25, 2020