Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Prostaglandin E2 (PGE2)
Status: | Archived |
---|---|
Conditions: | Cancer, Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | April 2009 |
A Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Ex-Vivo 16, 16 Dimethyl-Prostaglandin E2 Expanded Umbilical Cord Blood Units
The purpose of this research study is to determine the effects of 16, 16
Dimethyl-Prostaglandin E2 (dmPGE2) treatment on umbilical cord blood units to be used in
transplantation. dmPGE2 treatment is being tested to see if it can improve the ability of
umbilical cord blood stem cells to grow after transplantation. The growth of stem cells
after transplantation is sometimes referred to as "engraftment". One of the major problems
after umbilical cord transplantation is the time required for engraftment. After
transplantation of two umbilical cord blood units, the average time to achieve engraftment
is 21 days. In addition, up to 10% of patients who undergo umbilical cord blood
transplantation never engraft, a potentially life-threatening condition. In laboratory
studies, treatment of umbilical cord blood stem cells with dmPGE2 was shown to enhance
engraftment.
- On the day of admission to the hospital, two intravenous catheters will be placed in
the large veins in the participant's upper chest underneath the collarbone. The
catheters will remain in place throughout the transplant.
- The chemotherapy portion of the treatment is called "Conditioning Therapy". The
chemotherapy is used to prepare the bone marrow space to receive the transplanted
umbilical cord blood units. It consists of three intravenous medications; fludarabine,
melphalan and antithymocyte globulin or thymoglobulin.
- Starting three days before transplant and every day for 6-9 months after the
transplant, participants will receive the immune suppressive drugs tacrolimus and
sirolimus. These drugs are used to prevent Graft-Vs.-Host-Disease (GVHD), which might
develop as the transplant engrafts.
- After the participant completes the "Conditioning Therapy", they will have their
transplant. The day of the transplant is referred to as Day 0. On the day of the
transplant, each cord blood unit will be thawed and washed in the laboratory and be
given through the central venous catheter. All participants receive 2 cord blood units
2-5 hours apart.
- As part of this research study some cord units will be treated in the laboratory with
dmPGE2 before it is given to the participant. 3 different dmPGE2 treatment groups will
be tested. Group 1: will have the second cord blood unit treated; Group 2: will have
their first cord blood unit treated and; Group 3 will expand the experience of treating
the first cord blood unit. The three groups will be treated sequentially. If the
treatment strategy in Group 1 is deemed to be safe, Group 2 will be treated. If there
is evidence that the treated umbilical cord blood units from Groups 1 and 2 are
engrafting, and that the treatment is safe, Group 3 will be tested.
- Participants will also be treated with antibiotics to prevent and treat infection.
They may also receive transfusions of red blood cells and platelets. To help with
engraftment, they will be given the drug G-CSF (Neupogen) starting five days after the
transplant and until their white blood cells recover.
- After participants leave the hospital, they will be required to come back for
monitoring and routine care very frequently. This is standard after umbilical cord
blood transplantation.
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