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Clinical Trial: Chemotherapy with Hematopoietic Stem Cell Support for Children with High Risk Solid Tumors and Lymphomas
This study is currently recruiting patients.
Verified by St. Jude Children''''s Research Hospital September 2005
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Purpose
Several tumors, including advanced stage neuroblastoma diagnosed in children more than one year of age, metastatic sarcomas, many central nervous system tumors, recurrent lymphomas and recurrent Wilms tumors continue to have poor outcomes with current therapies. Thus, new therapies are being investigated, including autologous hematopoietic stem cell transplantation. This study will investigate using Busulfan and Melphalan chemotherapeutic agents, followed by an infusion of selected CD133+ hematopoietic cells (type of stem cell).
| Condition | Intervention |
|---|---|
| Neuroblastoma Central Nervous System Tumors Lymphomas Wilms Tumor | Procedure: Stem Cell Transplantation Drug: Busulfan, Melphalan |
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Lymphoma; Neuroblastoma; Neurologic Diseases; Wilms'''' Tumor
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Busulfan and Melphalan with Autologous Hematopoietic Stem Cell Support with Positively-Selected CD133+ Hematopoietic Cells for Children with High Risk Solid Tumors and Lymphomas
Further Study Details:
Primary Outcomes: Determine the safety of the treatment plan using Busulfan and Melphalan followed by an infusion of CD133+ selected hematopoietic cells.; To look at the purity of the stem cell product after filtering.; To help improve survival rates and decrease toxicity for subjects considered high risk for treatment failure.; Secondary outcomes:
Expected Total Enrollment: 34
Expected Total Enrollment: 34
Study start: August 2003
Eligibility
Ages Eligible for Study: up to 25 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Less than or equal to 25 years old at initial diagnosis.
- Diagnosis of high risk solid tumor malignancy.
- Adequate lung, kidney and liver function and adequate performance status.
- Adequate volume of bone marrow or peripheral stem cells for back up and infusion.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00152126
Gregory Hale, M.D. 1-866-278-5833 info@stjude.org
Tennessee
St. Jude Children''''s Research Hospital, Memphis, Tennessee, 38105, United States; Recruiting
Gregory Hale, M.D. 866-278-5833 Info@stjude.org
Study chairs or principal investigators
Gregory Hale, M.D., Principal Investigator, St. Jude Children''''s Research Hospital
More Information
St. Jude Children''''s Research Hospital
Study ID Numbers: ST133
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152126
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152126
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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