Current Studies
Cancer - Hematology/Oncology
IRB Number
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# 20615
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| Description |
This study will examine the
toxicity of using allogeneic stem cell transplantation for treatment of
subjects with relapsed or refractory pediatric solid tumors. Donors will
consist of either HLA identical or 9/10 (A, B, C, DR, DQ) matched related or
unrelated donors, or HLA (A, B, DR) 6/6 or 5/6 cord blood stem cells from a
related or unrelated donor. Specifically, we will examine: 1] The toxicity
of allogeneic stem cell transplant in this patient population, as related to
incidence of grade 3-4 acute GVHD. 2] The incidence of transplant related
mortality at 100 days. |
| What is expected of me? |
Subject will under go an
allogeneic stem cell transplant with Busulfan and Melphalan conditioning for
relapsed, refractory solid tumors. A physical examination, medical history,
blood testing, including liver & kidney function, hepatitis virus B and C,
HIV and pregnancy test (if applicable). Tests to monitor lung and heart
function. Evaluations and biopsies to monitor GVHD.X-rays, CT or MRI scan
for tumor measurements at 1, 3, 6 and 12 months and then at least annually
thereafter. |
| Inclusion Criteria |
Patients aged 0-30 years with relapsed or therapy refractory solid tumors,
excluding patients with brain tumors and patients with brain metastases.
Cord blood donors must be HLA 5/6, or 6/6 (A, B, DR) matched with the
recipient, and the cord blood specimen must contain ³ 2 x 107 nucleated
cells/kg body weight. Related and unrelated marrow and peripheral blood
stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the
recipient. |
| Exclusion Criteria |
Patients with the following findings are ineligible: cardiac rejection
fraction <50%, Creatinine Clearance<50%, Bilirubin >3, DLCO < 70%,
Lansky Score < 70 or ECOG Score > 2. Patients with an isolated local
recurrence of their tumor (in the site of the primary tumor) > 1 year
after completing therapy are excluded, as these patients could be cured
with local therapy alone. |
| Length of Study |
1 Year |
| Study Location |
Penn State Milton S. Hershey
Medical Center |
| Investigator Information |
Kenneth G. Lucas, M.D.
Pediatric Hematology / Oncology |
| To obtain more information about this study please contact: |
Swati Shah, CCRP
(717) 531-6012
sshah@psu.edu |
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