Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
The goal of this clinical research study is to learn if giving Avastin (bevacizumab) with standard chemotherapy and a blood stem cell transplant, in patients with an advanced solid tumor, can help to shrink the tumor or slow its growth. The safety of this treatment will also be studied.
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor|
- Progression-free Survival (PFS) [ Time Frame: 100 days after transplant ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2007|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
Other Names:Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Stem Cell Transplantation on Day 8.
Other Name: NSTDrug: Fludarabine
25 mg/m^2 IV Daily Over 30 Minutes for 5 Days
Other Name: Fludarabine PhosphateDrug: Melphalan
70 mg/m^2 IV Daily Over 30 Minutes for 2 DaysDrug: 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.
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Please refer to this study by its ClinicalTrials.gov identifier: 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|