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Sponsored by: |
Milton S. Hershey Medical Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112645 |
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 transplanted cells from a donor can make an immune response against the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin before transplant and cyclosporine with methylprednisolone or methotrexate after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating young patients with relapsed or refractory solid tumors.
Condition | Intervention | Phase |
Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclosporine Drug: melphalan Drug: methotrexate Drug: methylprednisolone Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase I |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Neuroblastoma Soft Tissue Sarcoma |
ChemIDplus related topics: | Melphalan Methotrexate Methylprednisolone Cyclosporine Cyclosporin Melphalan hydrochloride Sarcolysin Busulfan |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease |
Estimated Enrollment: | 10 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Related or unrelated hematopoietic stem cell donor available, meeting 1 of the following criteria:
Matched for HLA-A, -B, and -DR (5/6 or 6/6 allelles) (cord blood)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Pennsylvania | |||||
Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting | ||||
Hershey, Pennsylvania, United States, 17033-0850 | |||||
Contact: Kenneth G. Lucas, MD 717-531-6012 klucas@psu.edu |
Milton S. Hershey Medical Center |
Principal Investigator: | Kenneth G. Lucas, MD | Milton S. Hershey Medical Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000430441, PSCI-20615 |
First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112645 |
Health Authority: | Unspecified |
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