Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Ronald Hoffman
Study ID
NCT00667277
Phase
PHASE2
Status
Terminated

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • bevacizumab (Avastin) — DRUG
    15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)

Study Details

Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are produced) by fibrous tissue which reduces the body's ability to produce new blood cells and results in the development of chronic anemia (low red blood cell count). One of the main distinctions of myelofibrosis is "extramedullary hematopoiesis", the migration or traveling of the blood-forming cells out of the bones to other parts of the body, such as the liver or spleen, resulting in an enlarged spleen and liver. There is not a standard treatment for myelofibrosis, therefore there is no medication that is specifically used in the treatment of myelofibrosis. Bevacizumab (Avastin®) targets and stops a growth factor in the body that helps produce the type of fibrous tissue that is gradually replacing the bone marrow in the bones. The purpose of this study is to find out how safe and effective bevacizumab is in treating myelofibrosis. The investigators also wish to find out important biologic characteristics or features of myelofibrosis (how it works and operates) during the time of study participation through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker study is to understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases, while the main study is trying to find out how well bevacizumab will work in treating the disease.

Key Dates

First listed
Apr 28, 2008
Start date
Mar 31, 2008
Status verified
Aug 2014
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

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

Arms

  • Experimental: bevacizumab (Avastin)
    Use of bevacizumab (Avastin) in the treatment of myelofibrosis.

Primary Outcome Measure

Reason for Therapy Discontinuation [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-
University of Illinois at ChicagoChicagoIllinois60612-
Weill CornellIthacaNew York14851-
Mount Sinai Medical CenterNew YorkNew York10029-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Washington D.C., DC

By research site
Georgetown University· Washington D.C., DCUniversity of Illinois at Chicago· Chicago, ILWeill Cornell· Ithaca, NYMount Sinai Medical Center· New York, NYMD Anderson Cancer Center· Houston, TX

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