Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

Part of paid clinical trials in San Francisco, California.

Sponsor
Mt. Sinai Medical Center, Miami
Study ID
NCT01048554
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
    Temozolomide 75mg/m2 for six continuous weeks
  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg every 2 weeks without interruption

Study Details

This research is being done because melanoma in the brain is very difficult to treat because it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons for this is that the melanoma can make chemicals that signal the brain to provide new blood vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will stop the melanoma from growing.

Key Dates

First listed
Jan 13, 2010
Start date
Nov 30, 2009
Status verified
Apr 2012
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Temozolomide/Bevacizumab
    Patients will be treated with a combination of temozolomide at 75 mg/m2/day for six continuous weeks, followed by a two-week rest period and bevacizumab 10 mg/kg every 2 weeks without interruption. Cycles will be repeated every 8 weeks. Patients will be restaged every 8 weeks.

Primary Outcome Measure

Primary Outcome Measures: one-year survival rate [ Time Frame: one year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Saint Mary's Medical Center, 6th FloorSan FranciscoCalifornia94117-
The Angeles Clinic and Research InstituteSanta MonicaCalifornia90404-
Mount Sinai Medical CenterMiami BeachFlorida33140-

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Saint Mary's Medical Center, 6th Floor· San Francisco, CAThe Angeles Clinic and Research Institute· Santa Monica, CAMount Sinai Medical Center· Miami Beach, FL

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