Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
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|ClinicalTrials.gov Identifier: NCT00523809|
Recruitment Status : Terminated (Slow accrual.)
First Posted : September 3, 2007
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer||Drug: Bevacizumab Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Drug: Fludarabine Drug: Melphalan Drug: Thymoglobulin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Bevacizumab + Fludarabine + Melphalan
Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
10 mg/kg IV Daily Over 30 Minutes for 1 Day
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Stem Cell Transplantation on Day 8.
Other Name: NST
25 mg/m^2 IV Daily Over 30 Minutes for 5 Days
Other Name: Fludarabine Phosphate
70 mg/m^2 IV Daily Over 30 Minutes for 2 Days
0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.
- Progression-free Survival (PFS) [ Time Frame: 100 days after transplant ]Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523809
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|