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A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas


Phase 2
1 Year
N/A
Open (Enrolling)
Both
Advanced Cancers, Sarcoma

Thank you

Trial Information

A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas


The Study Drugs:

Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer
cells, which may cause them to die.

Surgery and Study Drug Administration:

If you are found to be eligible, the 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 didn't take part in this study. You will
be given a separate consent form to sign that explains the details and risks of abdominal
surgery in more detail.

During the surgery you will receive sodium thiosulfate by vein. The abdomen will then be
temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated
cisplatin will be delivered through plastic tubing that is connected to a pump into the
abdomen. The pump pushes the heated cisplatin into the abdomen and then pulls it out and
recirculates the cisplatin. 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 cisplatin in and out of the abdomen over 90 minutes while
the surgeon gently presses on the abdominal wall so the cisplatin reaches all areas in the
abdomen. After 90 minutes, the cisplatin 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 tumor samples will be sent to the laboratory of Dr. Dina Lev 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. The samples will
be destroyed after these tests are complete.

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 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,
including measurement of your weight and vital signs.

Follow-Up Visits:

About 1, 3, and 6 months after the surgery is complete, you will have follow-up visits and
the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 1 teaspoon) will be drawn at the 1 month visit only for routine tests.

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

- Blood (about 3 teaspoons) will be drawn for routine tests at the 3 and 6 month visits
only.

- At the 3 and 6 month visits only, you will have a CT scan, PET-CT scan, or MRI scan to
check the status of the disease.

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 operation
and study drug administration. If you are eligible for a re-perfusion, your 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 cisplatin in patients with abdominal sarcoma-type tumors is
investigational.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Age greater than or equal to 1 years

2. Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from
desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other
non-carcinoma tumors.

3. Radiologic workup must demonstrate that the disease is confined to the abdominal
cavity

4. 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 cm thickness per
tumor deposit

5. Patients must have a minimum expected duration of survival of greater than 6 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 as determined by anesthesia preoperative evaluation. This
includes but is not limited to, sepsis, liver failure, pregnant or lactating females.

7. Patients must have fully intact mental status and normal neurologic abilities. Intact
mental status is defined by 'the capacity to identify and recall one's identity and
place in time and space.' Assessment of mental status and documentation of fully
intact mental status will be completed using physical and mental exam by the
referring doctor or oncologist.

8. Patients must have adequate renal function (serum creatinine history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2
if less than 5 years of age)

9. Patients will be eligible if the WBC is >/=2000/microliter or ANC is >/=1,500, or
platelets are >/= 100,000/mm^3

10. Patients will be eligible if serum total bilirubin and liver enzymes are the upper limit of normal

11. 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
treatment

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 will be ineligible if they have disease outside of the abdominal cavity
which is uncontrolled

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

4. Patients who have failed previous intraperitoneal platinum therapy will be ineligible

5. Patients with Retroperitoneal Liposarcoma will be ineligible.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Relapse

Outcome Description:

About 1, 3, and 6 months after surgery is complete, follow-up visits and the following tests and procedures will be performed: A CT scan, PET-CT scan, or MRI scan to check the status of the disease. Efficacy assessed with primary endpoint of time to relapse.

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Andrea Hayes-Jordan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0528

NCT ID:

NCT01277744

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Sarcoma
  • Desmoplastic small round cell tumor
  • DSRCT
  • Hyperthermic peritoneal perfusion
  • HIPEC
  • Complete abdominal tumor excision
  • Extensive abdominal disease
  • Non-carcinoma tumors
  • Abdominal cavity
  • Cisplatin
  • Platinol-AQ
  • Platinol
  • CDDP
  • Diffuse peritoneal tumor
  • Retroperitoneal tumor
  • Ovarian germ cell
  • Wilms' tumor
  • Fever
  • Desmoplastic Small Round Cell Tumor
  • Neoplasms
  • Sarcoma

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030