Escalating Doses of Oxaliplatin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Children and Adolescents With Extensive Colon Carcinoma
Condition: Colorectal Cancer
MeSH terms: Colorectal 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
      intra-abdominal oxaliplatin that can be given to patients with colon cancer. Researchers also
      want to learn more about the ways that pediatric and young adult colon cancer may be
      different from colon cancer in adults.
    

Detailed description: 
      Surgery and Study Drug Administration:

      If you are found to be eligible to take part in this study, 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 did not
      take part in this study. You will be given a separate consent form to sign that explains the
      details and risks of surgery in more detail.

      During surgery, the abdomen will be temporarily closed. Then the abdominal wash will begin.
      During the "abdominal wash," heated oxaliplatin will be delivered through plastic tubing that
      is connected to a pump into the abdomen. The pump pushes the heated oxaliplatin into the
      abdomen and then pulls it out and recirculates the oxaliplatin. 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 oxaliplatin in and out of the
      abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the
      oxaliplatin reaches all areas in the abdomen. After 90 minutes, the oxaliplatin 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 tissue samples (tumor and normal abdominal tissue), 2 tablespoons of blood
      will be sent to the laboratory of Dr. Scott Kopetz 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.

      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 Day 1 after surgery:

        -  Blood (about 1 teaspoon) will be drawn for routine tests.

        -  You will have a physical exam.

      On Days 2-5, 11, 14, and 30 after surgery:

        -  Blood (about 1-3 teaspoons) will be drawn for routine tests.

        -  You will have a physical exam.

        -  On Day 30 only, you will have a hearing test.

      If the doctor thinks it is needed, you will also have follow up visits at 3 and 6 months
      after surgery. If these visits occur here at MD Anderson, you will not have a hearing test,
      but you will have an MRI, CT, or PET-CT scan to check the status of the disease. The 3 and 6
      month visits following 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 for a re-perfusion, which is a repeat of the surgery and
      study drug administration. If you are eligible for a re-perfusion, your participation on this
      study will end and 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. Oxaliplatin 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 heated oxaliplatin given intra-abdominally in pediatric patients
      with colon cancer is investigational. The study doctor can explain how the study drug is
      designed to work.

      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
    

Intervention name(s): Oxaliplatin
Intervention type(s): Drug
Intervention description(s): Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.
Other intervention name(s): Eloxatin
Intervention MeSH terms: Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal cancer; Colon Cancer; Pediatric; Adolescent; Hyperthermic Intraperitoneal Chemotherapy; HIPEC; Oxaliplatin; Eloxatin