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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

Phase 1
3 Years
18 Years
Not Enrolling
Peritoneal Neoplasms, Retroperitoneal Neoplasms, Gastrointestinal Neoplasms, Adenocarcinoma, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Adrenocortical Carcinoma, Wilms Tumor, Rhabdomyosarcoma, Desmoplastic Small Round Cell Tumor

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Trial Information

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

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

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.

Inclusion Criteria:

1. Age greater than or equal to 3 and less than or equal to 18 years

2. Histologically proven diffuse peritoneal or retroperitoneal tumor from the following
histologies: adenocarcinoma of the gastrointestinal tract, desmoplastic round cell
tumor, late stage neuroblastoma, ovarian germ cell, sarcoma, adrenocorticocarcinoma,
Wilms', rhabdomyosarcoma. (target groups: desmoplastic small round cell tumor
(DSRCT), neuroblastoma, and recurrent tumors). If tumors are outside the abdominal
cavity, the tumors must be controllable.

3. All patients must have refractory or recurrent tumors with no known curative
treatment options.

4. Radiologic workup must demonstrate that the disease is confined to the abdominal
cavity. If tumors are outside the abdominal cavity, the tumors must be able to be

5. Radiologic workup or prior abdominal exploration must be consistent with disease
which can be debulked to a residual size of less than or equal to 1 mm thickness per
tumor deposit

6. Patients must have minimum expected duration of survival of greater than 6 weeks

7. Patients must not have any systemic illness which precludes them from being an
operative candidate. This includes but is not limited to sepsis, liver failure,
pregnancy, lactating females.

8. Patients must have fully intact mental status and normal neurologic abilities.

9. Patients must have adequate renal function (serum creatinine dialysis or renal failure)

10. Patients will be eligible if the white blood count (WBC) is > or =2,000/ul or
Absolute neutrophil count (ANC) is > or =1,500, or platelets are > or = 100,000/mm^3

11. Patients will be eligible if serum total bilirubin and liver enzymes (aspartate
aminotransferase (AST) or alanine aminotransferase (ALT)) are limit of normal

12. 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

13. If tumors are outside the abdominal cavity, the tumors must be controllable.

Exclusion Criteria:

1. Patients who have failed previous continuous hyperthermic intraperitoneal perfusion
with platinum therapy will be ineligible

2. Patients with tumors that are unable to be controlled outside the abdominal cavity
will be ineligible

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

4. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or
greater (because of the potential neurotoxicity associated with platinum)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin in children with peritoneal cancer

Outcome Description:

The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

Outcome Time Frame:

Assessed during treatment and post surgery through hospital stay (estimated 5 days) followed one month later.

Safety Issue:


Principal Investigator

Andrea Hayes-Jordan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

April 2011

Related Keywords:

  • Peritoneal Neoplasms
  • Retroperitoneal Neoplasms
  • Gastrointestinal Neoplasms
  • Adenocarcinoma
  • Neuroblastoma
  • Ovarian Neoplasms
  • Sarcoma
  • Adrenocortical Carcinoma
  • Wilms Tumor
  • Rhabdomyosarcoma
  • Desmoplastic Small Round Cell Tumor
  • Children
  • Pediatric
  • Peritoneal Tumor
  • Retroperitoneal Tumor
  • Gastrointestinal Adenocarcinoma
  • Desmoplastic Round Cell Tumor
  • Neuroblastoma
  • Ovarian Germ Cell
  • Sarcoma
  • Adrenocorticocarcinoma
  • Wilms' Tumor
  • Rhabdomyosarcoma
  • Desmoplastic Small Round Cell Tumor
  • Recurrent Tumors
  • Cisplatin
  • Platinol┬«-AQ
  • Platinol┬«
  • CDDP
  • Abdominal Wash
  • Hyperthermic Perfusion
  • Continuous Hyperthermic Peritoneal Perfusion
  • CHPP
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Fever
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Wilms Tumor
  • Neuroblastoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Retroperitoneal Neoplasms
  • Rhabdomyosarcoma
  • Adrenocortical Carcinoma
  • Desmoplastic Small Round Cell Tumor
  • Peritoneal Diseases
  • Sarcoma



UT MD Anderson Cancer Center Houston, Texas  77030