Administration of High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors
High Dose Thiotepa and Melphalan With Autologous Hematopoietic Stem Cell Transplant in Children and Adolescents With Solid Tumors
1 other identifier
interventional
20
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedFebruary 6, 2008
January 1, 2008
4.5 years
January 23, 2008
February 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival
10 yeaer follow up
Secondary Outcomes (1)
toxicity
180 days
Study Arms (1)
single
EXPERIMENTALInterventions
thiotepa 900 mg per meter squared total, on days -11,-10,-4,-3 melphalan 140 mg per meter squared total on days -11,-10,-4,-3 autologous stem cell transplant in day 0
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, 49202, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Stein, MD
Schneider Children's Medical Center, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
June 1, 2006
Primary Completion
December 1, 2010
Last Updated
February 6, 2008
Record last verified: 2008-01