Status:
TERMINATED
Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors
Lead Sponsor:
Emory University
Conditions:
High Risk Solid Tumors
Recurrent Solid Tumors
Eligibility:
All Genders
Up to 35 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Patients diagnosed with high risk recurrent or refractory solid tumors following initial chemotherapy
- 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.
- Patients who are under 35 years of age.
- Patients with a life expectancy of at least 8 weeks and performance status (Karnofsky or Lansky score) of at least 70%.
- Patients who are acceptable candidates for peripheral blood stem cell transplantation based on their pre-transplant evaluation.
Exclusion
- Patients will not be excluded based on sex, race.
- Patients with central nervous system tumors are not eligible for this protocol.
- Patients have significant functional deficits in major organs which would interfere with successful outcome following PBSCT.
- Patients who have been treated for infections must have appropriate responses as documented by negative cultures and/or a normal radiographic examination.
- Patients may not have active CNS disease or marrow involvement with the tumor at the time of transplant.
- Patients with disease progression after tandem PBSC #1 will not be eligible for tandem PBSC #2.
- Patients will be excluded if they are women of childbearing potential who are currently pregnant (HCG+) or who are not practicing adequate contraception.
- Patients who have had a previous stem cell transplant.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00966498
Start Date
May 1 2003
End Date
July 1 2011
Last Update
December 11 2013
Active Locations (2)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Emory University
Atlanta, Georgia, United States, 30322