Trial Outcomes & Findings for Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor (NCT NCT00523809)

NCT ID: NCT00523809

Last Updated: 2013-01-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 100 days after transplant
• Results posted on: 2013-01-28

Participant Flow

Recruitment Period: August 30. 2007 through November 2, 2010. All recruitment was done at UT MD Anderson Cancer Center.

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

Baseline characteristics by cohort

Measure	Bevacizumab + Fludarabine + Melphalan n=5 Participants 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.
Age Continuous	55 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days after transplant

Population: Study objectives were not meet, analysis was not performed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab + Fludarabine + Melphalan

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab + Fludarabine + Melphalan n=5 participants at risk 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.
Gastrointestinal disorders Diverticulitis	20.0% 1/5 • 1 year and 7 months
Investigations Death	20.0% 1/5 • 1 year and 7 months
Cardiac disorders Cardiac toxicity, reduced ejection fraction	20.0% 1/5 • 1 year and 7 months
General disorders Headache	20.0% 1/5 • 1 year and 7 months

Other adverse events

Measure	Bevacizumab + Fludarabine + Melphalan n=5 participants at risk 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.
Reproductive system and breast disorders Vaginal bleed	20.0% 1/5 • 1 year and 7 months
Reproductive system and breast disorders Hot flash	20.0% 1/5 • 1 year and 7 months
Reproductive system and breast disorders Vaginal itch	20.0% 1/5 • 1 year and 7 months
Reproductive system and breast disorders Vaginal dryness	20.0% 1/5 • 1 year and 7 months
Reproductive system and breast disorders Mild breast pain	20.0% 1/5 • 1 year and 7 months
Reproductive system and breast disorders Face swelling	20.0% 1/5 • 1 year and 7 months
Psychiatric disorders Mild depression	20.0% 1/5 • 1 year and 7 months
General disorders Headache	20.0% 1/5 • 1 year and 7 months
Investigations Abdominal tenderness	20.0% 1/5 • 1 year and 7 months
Psychiatric disorders Insomnia	20.0% 1/5 • 1 year and 7 months
Gastrointestinal disorders Nausea	20.0% 1/5 • 1 year and 7 months
Gastrointestinal disorders Vomiting	20.0% 1/5 • 1 year and 7 months

Additional Information

Naoto Ueno, MD / Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place