Status:
COMPLETED
Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Neuroblastoma
Sarcoma
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief Summary
RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the t...
Detailed Description
OBJECTIVES: * Determine the toxicity of allogeneic hematopoietic stem cell transplantation, in terms of the incidence of grade 3-4 acute graft-versus-host disease, in young patients with relapsed or ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of relapsed or refractory solid tumor, including, but not limited to, relapsed neuroblastoma, relapsed Ewing's sarcoma, and relapsed rhabdomyosarcoma
- No isolated local disease recurrence at the site of the primary tumor \> 1 year after completion of prior therapy
- No brain tumor or brain metastases
- Related or unrelated hematopoietic stem cell donor available, meeting 1 of the following criteria:
- Matched for HLA-A, -B, -C, -DR, and -DQ (9/10 or 10/10 allelles) (marrow or peripheral blood)
- Matched for HLA-A, -B, and -DR (5/6 or 6/6 allelles) (cord blood)
- Cord blood specimen must contain ≥ 2 x 10 \^7 nucleated cells/kg body weight
- PATIENT CHARACTERISTICS:
- Age
- 30 and under
- Performance status
- ECOG 0-1 OR
- Lansky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 3.0 mg/dL
- Renal
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- Ejection fraction ≥ 50%
- Pulmonary
- DLCO ≥ 70% OR
- O\_2 saturation ≥ 95% on room air
- Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior autologous stem cell transplantation allowed
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00112645
Start Date
April 1 2005
End Date
February 1 2011
Last Update
July 18 2013
Active Locations (1)
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1
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850