Malignant Neoplasms of Mesothelial and Soft Tissue Clinical Trial
Official title:
A Phase I Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children
The goal of this clinical research study is to find the highest tolerable dose of heated doxorubicin that can be given to patients during surgery with abdominal tumors. The safety of this drug will also be studied.
Surgery and Study Drug Administration:
If participant is found to be eligible to take part in this study, surgery will be performed
to try to remove as many tumors from participant's abdomen as possible. The surgery is not
being performed specifically for this research study and would be performed as part of
participant's standard of care treatment even if participant didn't take part in this study.
Participant will be given a separate consent form to sign that explains the details and risks
of the abdominal surgery in more detail.
During the surgery, if it is decided that all of the tumors can be removed, the abdomen will
be closed with a plastic tube left in place. Then, the abdominal wash will begin. During the
wash, a pump that is connected to the plastic tube pushes the heated doxorubicin into the
abdomen and then pulls it out to recirculate the doxorubicin. The heated doxorubicin will be
recirculated in and out of the abdomen over 90 minutes while the surgeon gently presses on
the abdomen to help the doxorubicin reach all areas in the abdomen. The plastic tube that the
heated doxorubicin 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 participant did
not agree to take part in this study.
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, as many of the tumors will be removed as possible, followed by brachytherapy and
the implantation of radioactive seeds. To perform brachytherapy, straws loaded with
radioactive seeds will be inserted into the abdominal area. The radiation will then take
place in the operating room over about 20 minutes. The straws will be removed before ending
the surgery. Participant may be able to return for the abdominal wash procedure 4 weeks after
the seeds have been implanted.
Pharmacokinetic Testing:
During participant's surgery, extra blood (about ½ teaspoon each time) and fluid from the
abdominal area will be collected for pharmacokinetic (PK) testing when participant begins to
receive the first infusion of the heated doxorubicin then 30, 60 and 90 minutes after the
infusion has started, and again 24 hours after receiving the heated doxorubicin. The blood
and fluid from the abdominal 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.
Length of Study:
Participant will remain on study for up to 6 months. Participant 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, participant may be eligible to have the operation with heated doxorubicin
wash repeated. If participant is eligible to have the surgery repeated, participant's active
participation on this study will end and then participant will be given a new consent form to
sign in order to be re-enrolled back onto this study.
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.
- Participant will have a physical exam.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, participant will have a follow-up
visit and the following tests and procedures will be performed:
- Participant will have a physical exam.
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- Participant will have an ECHO to check your heart function.
It is recommended that participant has follow-up visits at MD Anderson at 3 and 6 months
after surgery. In addition to blood draws (about 1-3 teaspoons each time), participant 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 participant's local doctor's office and/or
laboratory.
This is an investigational study. Doxorubicin is FDA-approved and commercially available. The
use of a heated doxorubicin wash during abdominal surgery in patients with tumors is
investigational. The study doctor can explain how the study drug is designed to work.
Up to 28 patients will take part in this study. All will be enrolled at MD Anderson.
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