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Monoclonal Antibodies
Bevacizumab for Lymphedema
Phase 1
Waitlist Available
Led By Michael S Gordon, MD
Research Sponsored by Premiere Oncology of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal end organ function defined as: serum creatinine < 1.5 mg/dl or a calculated creatinine clearance > 50 ml/min; SGOT and SGPT < 2.5 X upper limit of normal (ULN); total bilirubin < 1.5 X ULN; absolute neutrophil count (ANC) > 1,500 cells/µl; hemoglobin > 10 g/dl (without transfusions); platelet count > 100,000/µl; serum albumin within normal limits (WNL)
No known evidence of recurrent or active metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if the drug bevacizumab is safe and has side effects in people with lymphedema. The study will also help to find the right dose of bevacizumab to use in future studies.
Who is the study for?
This trial is for women who have had breast cancer surgery, suffer from mild to moderate lymphedema (swelling of the arm), and are not currently receiving manual lymphatic drainage or combined decongestive therapy. Participants must have normal organ function, no recent chemotherapy, and no history of significant cardiovascular events or untreated high blood pressure. Pregnant women and those with severe lymphedema or bleeding disorders cannot join.Check my eligibility
What is being tested?
The study tests the safety of Bevacizumab alone and in combination with standard therapies for lymphedema—manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). It aims to find the right dose for future research on patients with this condition.See study design
What are the potential side effects?
Potential side effects include increased risk of bleeding, hypertension, proteinuria (excess protein in urine indicating kidney issues), gastrointestinal perforations, wound healing complications, arterial thromboembolic events like stroke or heart attack, infusion reactions, fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney, liver, and blood counts are within normal ranges.
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I do not have any signs of breast cancer returning or spreading.
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I had breast cancer surgery and now have swelling in my arm or leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,654 Total Patients Enrolled
Premiere Oncology of ArizonaLead Sponsor
Michael S Gordon, MDPrincipal InvestigatorPremiere Oncology of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling in both arms or legs.I have a history of blood clots, heart attack, stroke, or other blood vessel blockages.I have a history of heart failure that affects my daily activities.I agree to use barrier contraception during and 3 months after the study.My condition is Stage III lymphedema.My kidney, liver, and blood counts are within normal ranges.I have a bleeding disorder.My blood pressure is higher than 150/100 mmHg and I haven't treated it.My lymphedema is mild to moderate, with either pitting or some fibrosis.I haven't had chemotherapy in the last 6 months and have recovered from its side effects, except for hair loss.I have been receiving lymph drainage or compression bandaging treatments recently.I do not have any signs of breast cancer returning or spreading.I have had infections in my arm or cannot undergo certain lymph drainage treatments.I had breast cancer surgery and now have swelling in my arm or leg.I am on blood thinners or medications like aspirin that affect blood clotting.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks do individuals face when undergoing this procedure?
"The safety of this particular treatment is appraised at a 1, as Phase 1 trials have only minimal evidence to gauge its efficacy and security."
Answered by AI
Are participants of this experiment required to be older than thirty?
"This particular experiment is seeking patients who are below 0 years old and above the age of infancy."
Answered by AI
Does my profile qualify me to take part in this exploration?
"This clinical trial is seeking volunteers between 0 to 0 years of age who are currently suffering from lymphedema. Additional requirements include: Lymphedema must be at either Stage I (pitting) or II (fibrosis); no prior chemotherapy in the last 6 months, with all side-effects having subsided; women with a history of breast cancer post surgical resection and lymphedema defined as an arm volume difference of 500 ml by perometric assessment."
Answered by AI
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