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Monoclonal Antibodies

Bevacizumab + Doxorubicin + Radiation for Sarcoma

Phase 1
Waitlist Available
Led By Edwin Choy, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary tumor must be at least 5 cm in maximal diameter or an isolated local recurrence of any size
Histologically intermediate- or high-grade soft tissue sarcoma
Must not have
History of myocardial infarction, acute coronary syndromes, coronary angioplasty or coronary artery stenting within previous 6 months
Known hypercoagulable disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of the combination of bevacizumab with doxorubicin and radiation.

Who is the study for?
This trial is for adults with intermediate- or high-grade soft tissue sarcoma that can be surgically removed, located on limbs, trunk, or pelvis. The tumor must be at least 5 cm across or a local recurrence of any size without prior radiation. It's not for those with metastatic disease, pregnant/breastfeeding individuals, recent major surgery patients, people who have had doxorubicin/anthracycline chemotherapy/bevacizumab before, or those with certain medical conditions.
What is being tested?
The study tests the safety and effectiveness of combining bevacizumab (a drug not yet approved for sarcomas) with doxorubicin chemotherapy and radiation therapy to find the maximum tolerated dose. As a Phase I clinical trial, it focuses on determining the right dosage for further research.
What are the potential side effects?
Potential side effects may include issues related to blood clotting disorders due to bevacizumab; heart problems from previous myocardial infarction; risks associated with bleeding diathesis/coagulopathy; and complications from recent surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My primary tumor is at least 5 cm wide or I have a local recurrence of any size.
Select...
My sarcoma is confirmed to be of intermediate or high severity.
Select...
My cancer is a primary or locally recurrent soft tissue sarcoma and I haven't had radiation before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had a heart attack or any heart procedures in the last 6 months.
Select...
I have a condition that makes my blood clot more than normal.
Select...
I have a history of blood clots in my veins or lungs.
Select...
I am currently taking blood thinners.
Select...
My cancer has spread to other parts of my body.
Select...
I have previously been treated with doxorubicin or similar drugs.
Select...
I have a bleeding disorder.
Select...
I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine MTD of bevacizumab+doxorubicin+radiation
Secondary study objectives
Microvessel density
Obtain preliminary data disease-free survival
Obtain preliminary data overall survival
+4 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
vitreous syneresis
9%
posterior capsule opacification
4%
cranial nerve VI palsy
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment3 Interventions
Bevacizumab, metronomic doxorubicin and radiation therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Doxorubicin
2012
Completed Phase 3
~8030
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,931 Total Patients Enrolled
15 Trials studying Sarcoma
2,468 Patients Enrolled for Sarcoma
Edwin Choy, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01746238 — Phase 1
Sarcoma Research Study Groups: Treatment Arm
Sarcoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01746238 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01746238 — Phase 1
~1 spots leftby Dec 2025
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