|Estimated Enrollment Submitted:||August/24/2009|
|Last Update Submitted:||December/8/2013|
|Last Update Posted:||December/10/2013|
|Actual Study Start Date:||April/30/2003|
|Estimated Primary Completion Date:||June/30/2011|
|Estimated Study Completion Date:||June/30/2011|
|Masking:||None (Open Label)|
This study is a single-arm, non-randomized trial. Peripheral blood stem cells will be harvested by mobilization with chemotherapy followed by G-CSF. Following adequate peripheral blood stem cell collection, the patients would be transplanted using the conditioning regimen consisting of thiotepa and cyclophosphamide (tandem one) and busulfan and melphalan (tandem two). They will receive G-CSF post transplant. There will be 6-8 weeks interval between tandem transplants. All patients would be carefully observed for any toxicity, transplant-related complications, relapse and disease-free survival.
Peripheral Blood Stem Cell Transplant
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
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.