CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
graft versus host disease prophylaxis/therapy +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00357396
NCT00357396Phase 2Completed

A Phase II Trial of a Chemotherapy Based Regimen of Intravenous Busulfan (Busulfex), Melphalan and Thiotepa as Myeloablative Regimen Followed by a T- Cell Depleted Allogeneic Hematopoietic Stem Cell Transplant From and HLA-Compatible Donor in the Treatment of High Risk Ewing's Sarcoma Family Tumors

Memorial Sloan Kettering Cancer Center·interventional·Posted Jul 27, 2006·Updated Nov 25, 2015

In Brief

A Phase 2 clinical trial evaluating graft versus host disease prophylaxis/therapy, busulfan, and 5 other interventions for Sarcoma. Completed, enrolled 10 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate mofetil may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewing's tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2006
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.9 years ago

Interventions

graft versus host disease prophylaxis/therapybiological

busulfandrug

melphalandrug

thiotepadrug

allogeneic bone marrow transplantationprocedure

allogeneic hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure