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

NCT01048554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-04-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Temozolomide

Temozolomide 75mg/m2 for six continuous weeks

DRUG

Bevacizumab

Bevacizumab 10mg/kg every 2 weeks without interruption

Sponsors & Collaborators

  • Northern California Melanoma Center

    collaborator OTHER

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Jose Lutzky, MD · Mt Sinai Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048554 on ClinicalTrials.gov