Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
Condition: Lung Cancer
MeSH terms: Neoplasms; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Cisplatin; Amifostine
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C).; Amifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion.
Other intervention name(s): Platinol-AQ; Platinol; CDDP; Ethyol; Ethiofos; Gammaphos
Intervention MeSH terms: Cisplatin; Amifostine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Cancer; Unilateral Pleural Malignancy; Metastatic active pleural malignancy; Lung tumors; Sarcomas; Cytoreductive Surgery; Hyperthermic Intrathoracic Pleural Chemotherapy; HITC; Cisplatin; Platinol-AQ; Platinol; CDDP; Amifostine; Ethyol; Ethiofos; Gammaphos