Tumors Clinical Trial
Official title:
High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors
NCT number | NCT00607984 |
Other study ID # | 3990 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | January 23, 2008 |
Last updated | February 5, 2008 |
Start date | June 2006 |
The prognosis of children and adolescents with high risk tumors of the central nervous system and other miscellaneous solid tumors is poor despite modern treatment protocols. Frequently, physicians suggest additional therapy with high dose chemotherapy after a good initial response to standard doses of treatment has been obtained, so as to reduce the chance that the tumor will recur. We propose a regimen of high dose thiotepa and melphalan followed by rescue of the patient's previously stored hematopoietic (blood manufacturing) system with blood stem cells. The aim of this study is to prove that this therapy is tolerable in children and adolescents, that it results in tolerable levels of toxicity, and that it improves the survival of this group of children as compared to standard therapy given in the past
Status | Recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
Inclusion Criteria: - Age 1-21 years - CNS tumors, hepatic tumors and other solid tumors that are chemosensitive - Minimal disease as determined by either radiological studies or biochemical markers (as determined by treating physician). - Consent of patient or surrogate. Exclusion Criteria: - Not pregnant or nursing - Fertile patients must use effective contraception - No known HIV or AIDS infection - No active bacterial, fungal, or viral infection - No medical condition that would preclude study treatment - Positive pregnancy test or failure to use contraceptives. - Creatinine >1.5 times limit of normal for age - SGOT or SGPT more than 3 times normal. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Schneider Children's Medical Center of Israel | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | survival | 10 yeaer follow up | Yes | |
Secondary | toxicity | 180 days | Yes |
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