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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 β€œYes” 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.

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

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

Side effects data

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

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
~5280
Doxorubicin
2012
Completed Phase 3
~7940
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,341 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 β€” Phase 1
Sarcoma Research Study Groups: Treatment Arm
Sarcoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01746238 β€” Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01746238 β€” Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative medical experiment?

"Currently, Bevacizumab is the subject of 701 active trials conducted in multiple cities and countries around the world. The first clinical investigation was launched by Alfacell back in 1997; this trial included 300 participants over its Phase 3 evaluation period. Since then, 1747 separate experiments have been performed with regards to this drug."

Answered by AI

How many individuals are currently participating in this investigation?

"This research study is not presently accepting participants. It was launched on March 1st 2013 and last updated on April 6th 2022. For those looking for other studies, 443 trials are actively searching for sarcoma patients, while 701 studies offer Bevacizumab as a potential therapy."

Answered by AI

For what medical issues is Bevacizumab commonly prescribed?

"Bevacizumab is a proven treatment for recurrent platinum-sensitive epithelial ovarian cancer and can also be helpful in managing malignant neoplasms, persistent cervical cancer, and Kaposi's sarcoma related to AIDS."

Answered by AI

Has Bevacizumab been approved by the U.S. Food and Drug Administration?

"Bevacizumab scored a 1 on our safety scale, as the clinical trial is in its initial stages and existing data has yet to demonstrate established efficacy or patient security."

Answered by AI

Is this research actively seeking to enroll participants?

"This particular clinical trial, which was initially posted on March 1st 2013 and last updated on April 6th 2022 is not presently recruiting candidates. Nevertheless, there are 1144 other medical studies actively searching for patients at the moment."

Answered by AI

Has research ever been conducted related to the efficacy of Bevacizumab?

"Presently, 701 clinical trials for Bevacizumab are underway. Out of those studies, 205 have reached Phase 3. Notably, the bulk of these examinations are based in Taibei, Taiwan; however there are 38318 worldwide locations running such experiments."

Answered by AI
~1 spots leftby Apr 2025