Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors
Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors
Before the transplant, the patient will have a pre-transplant evaluation. This will help find
 out whether there are health problems that will prevent the transplant. It also provides
 "baseline" tests that will be used later to see whether or not organs have gotten better or
 worse after the transplant. Prior to the stem cell collection, the patient will get
 chemotherapy to help try to put him/her in remission and to push more stem cells into the
 peripheral blood (mobilization). The study doctor will decide which chemotherapy will be used
 for this part of the study. Once mobilization is completed, the peripheral blood stem cell
 collection (apheresis) will be done in the clinic. The apheresis machine will draw blood out
 of the central line. The blood then passes through the apheresis machine and the stem cells
 are separated out. The remaining blood is sent back through the central line. If the
 investigators are unable to collect enough peripheral blood stem cells, a bone marrow harvest
 may be necessary to collect more stem cells.

 The patient will then be admitted to the hospital for the first transplant. He/she will get
 Thiotepa and Cyclophosphamide. Then the patient will be given back the cells that were
 collected. The cells are given in the same manner as a blood transfusion. The patient will be
 kept in the hospital until he/she is stable and blood counts are increasing. Approximately 6
 to 8 weeks after Day 0 of the 1st transplant, the patient will be admitted for the second
 transplant. At this time, he/she will get Busulfan and Melphalan and then the collected cells
 will be given back. The patient will be kept in the hospital until he/she is stable and blood
 counts are increasing. Frequent clinic follow-up is required.

 This study is open to patients who are less then 21 years of age with refractory or relapsed
 high-risk, solid tumors, excluding neuroblastoma (there is a cooperative group trial for
 these patients). Patients will be identified by the Transplant team and eligibility will be
 verified by a member of the clinical research team. Patients will be cared for by members of
 the Transplant team and various other subspecialty physicians.
The optimal treatment for refractory (disease won't go away with standard treatment) or
 relapsed (disease comes back after going away) solid tumors is unknown. Recent studies have
 shown some benefit to tandem peripheral blood stem cell transplantation (PBSCT). In a tandem
 transplant, two transplants are done, one after the other. To do a PBSCT, stem cells ("mother
 cells" that can become any other type of cell) are first collected from the patient's
 circulating blood. The patient then undergoes high-dose chemotherapy called the preparative
 regimen. The preparative regimen destroys not only the tumor cells, but it also destroys all
 of the normal blood making cells. The collected cells are then given back to the patient to
 "rescue" the patient from the devastating effects of the preparative regimen. By using a stem
 cell rescue will are able to give much higher doses of chemotherapy than we would be able to
 give without the stem cell rescue. To make sure that all of the tumor cells are destroyed,
 patients in this study will undergo two separate transplants using two different preparative
 regimens. The preparative regimens will use the best agents that have been found to work
 against recurrent and refractory solid tumors: Busulfan, Thiotepa, Cyclophosphamide and
 Melphalan.
Inclusion Criteria:

 1. Patients diagnosed with high risk recurrent or refractory solid tumors following
 initial chemotherapy

 2. Tumor must be sensitive to chemotherapy (maximum 8 cycles) and/or radiation defined as
 a greater than 50% reduction in size of the primary and/or metastatic sites.

 3. Patients who are under 35 years of age.

 4. Patients with a life expectancy of at least 8 weeks and performance status (Karnofsky
 or Lansky score) of at least 70%.

 5. Patients who are acceptable candidates for peripheral blood stem cell transplantation
 based on their pre-transplant evaluation.

 Exclusion Criteria:

 1. Patients will not be excluded based on sex, race.

 2. Patients with central nervous system tumors are not eligible for this protocol.

 3. Patients have significant functional deficits in major organs which would interfere
 with successful outcome following PBSCT.

 4. Patients who have been treated for infections must have appropriate responses as
 documented by negative cultures and/or a normal radiographic examination.

 5. Patients may not have active CNS disease or marrow involvement with the tumor at the
 time of transplant.

 6. Patients with disease progression after tandem PBSC #1 will not be eligible for tandem
 PBSC #2.

 7. Patients will be excluded if they are women of childbearing potential who are
 currently pregnant (HCG+) or who are not practicing adequate contraception.

 8. Patients who have had a previous stem cell transplant.