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

Conditions:Lung Cancer, Cancer, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Age Range:3 - 21
Start Date:August 20, 2014
End Date:August 2019
Contact:Andrea Hayes-Jordan, MD

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

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.

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

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

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

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

Inclusion Criteria:

1. Age >/= 3 years to
2. Histologically or genetically proven unilateral primary or metastatic active pleural

3. Radiologic workup must demonstrate that the thoracic disease is confined to only one
hemi-thoracic cavity and must be deemed potentially resectable by the surgical team.

4. The extrathoracic disease must be controlled.

5. Patients must have a minimum expected duration of survival of 8 weeks as determined
and documented by the attending surgeon or medical oncologist.

6. Patients must not have any systemic illness which precludes them from being an
operative candidate.

7. Patients must have Adequate Renal Function Defined as: Creatinine clearance or
radioisotope GFR >/=70ml/min/1.73 m^2 or a serum creatinine based on age/gender less
than listed value in the table below: 1 to < 2 years 0.6 mg/dL for both males and
females, 2 to < 6 years 0.8 mg/dL for both males and females, 6 to < 10 years 1 mg/dL
for both males and females, 10 to < 13 years 1.2 mg/dL for both males and females, 13
to < 16 years 1.5 mg/dL for males and 1.4 mg/dL for females, >/= 16 years 1.7 for
males and 1.4 for females

8. Patients will be eligible if the WBC is >/=1500/µl or ANC is >/=1,000 and platelets
are >/= 50,000/mm^3

9. Adequate Liver Function Defined as: -Bilirubin (sum of conjugated + unconjugated) 1.5 x upper limit of normal (ULN) for age -SGPT (ALT) this study, the ULN for SGPT is 45 U/L. -Serum albumin >/= 2 g/dL.

10. Patients must be recovered from any toxicity from all prior chemotherapy,
immunotherapy, or radiotherapy and be at least 14 days past the date of their last

Exclusion Criteria:

1. Patients will be ineligible if they have any concomitant cardiopulmonary disease which
would place them at unacceptable risk for a major surgical procedure

2. Patients who have failed previous hemi-thoracic platinum therapy will be ineligible
("Failed" is having disease recurrence
3. No pregnant or lactating females.

4. Patients will be ineligible if they have a lymphoma diagnosis.
We found this trial at
1515 Holcombe Blvd
Houston, Texas 77030
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Houston, TX
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