Study Stopped
Slow accrual.
Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Aug 2007
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
January 28, 2013
CompletedJanuary 28, 2013
December 1, 2012
4.2 years
August 31, 2007
December 21, 2012
December 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
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.
100 days after transplant
Study Arms (1)
Bevacizumab + Fludarabine + Melphalan
EXPERIMENTALBevacizumab 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.
Interventions
10 mg/kg IV Daily Over 30 Minutes for 1 Day
Stem Cell Transplantation on Day 8.
25 mg/m\^2 IV Daily Over 30 Minutes for 5 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.
Eligibility Criteria
You may qualify if:
- From Age 18 to Age \</= 65 years old.
- Patients must have one of the following diseases. 1) metastatic breast cancer which achieved a tumor response (complete response (CR) or partial response (PR)) by pre-transplant therapy. For bone only metastatic breast cancer, a tumor response of stable disease (SD) is accepted. 2) low grade advanced ovarian cancer 3) high grade advanced ovarian cancer which achieved antitumor response (CR or PR) by pre-transplant therapy.
- Zubrod performance status \</= 1.
- An HLA-matched (6/6 matches) related donor or unrelated donor (8/8 matches) willing and able to donate peripheral blood stem cell (PBSC) or bone marrow and/or lymphocytes by conventional techniques.
- Requirement of prior treatment. For metastatic renal cell carcinoma (RCC) two prior treatments, which include targeted therapy (e.g. Sorafenib and Stutent). For breast and ovarian cancer, one prior treatment which include chemotherapy.
- Adequate major organ functions.
- Signed informed consent.
- Left ventricular ejection fraction \>/= 45%. Cardiology clearance is needed if the patient has left ventricular ejection fraction of \< 45%, uncontrolled arrhythmias, or symptomatic cardiac disease.
- Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), and carbon monoxide diffusing capacity (DLCO) \>/= 50% of predicted value. Pulmonary clearance is needed if the patient has FEV1, FVC, or DLCO \< 50% of predicted valued or any symptomatic pulmonary disease.
- Serum creatinine \</= 2.0 mg/dL, or creatinine clearance \> 40 mL/min.
- Serum bilirubin \</= 1.5 mg/dL, and serum glutamic-pyruvic transaminase (SGPT) \</= 3 \* upper limit of normal.
You may not qualify if:
- Prior history of allogeneic stem cell transplantation.
- Life expectancy is severely limited by concomitant illness.
- Clinically significant active infections.
- HIV infection.
- Chronic active hepatitis.
- Pregnant or lactating women.
- Presence of, or prior history of multiple brain metastasis. If patient has prior single brain metastasis treated with complete surgical resection or stereotactic radiation therapy, radiological imaging has to demonstrate no recurrence or no brain edema for at least 6 months from the end of the treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naoto Ueno, MD / Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Naoto Ueno, MD, PhD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 28, 2013
Results First Posted
January 28, 2013
Record last verified: 2012-12