Bevacizumab/Doxorubicin/Radiation for Sarcoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01746238
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Intravenous infusion, every 2 weeks, 3 doses total
  • Doxorubicin — DRUG
    Intravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks
  • Radiation Therapy — RADIATION
    Daily, Monday-Friday, for 6 weeks

Study Details

The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy. Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to subjects with sarcoma who are enrolled in this research study and may only be administered under the direction of doctors who are investigators in this research study. This study is being done because sarcomas can recur after surgical resection (surgery for removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the same location as the original tumor or in distant sites such as the lung. Thus better treatments are needed. This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, combination of drugs, or combination of drugs with radiation. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs and radiation is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of cancer.

Key Dates

First listed
Dec 10, 2012
Start date
Mar 31, 2013
Status verified
Apr 2026
Primary completion
May 31, 2016
Completion
Dec 31, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Bevacizumab, metronomic doxorubicin and radiation therapy

Primary Outcome Measure

Determine MTD of bevacizumab+doxorubicin+radiation [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies