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NCT01048554 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Mt. Sinai Medical Center, Miami.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT01048554: Completed Phase 2 study, sponsored by Mt. Sinai Medical Center, Miami.

NCT01048554 is a Phase 2 study that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01048554, a Phase 2 study, has completed, sponsored by Mt. Sinai Medical Center, Miami.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

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.

Interventions

  • DRUG Bevacizumab
  • DRUG Temozolomide

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2009-11
Est. Completion 2011-09
Phase Phase 2
Mt. Sinai Medical Center, Miami

13 total trials

What the finished NCT01048554 record still lists

NCT01048554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.

NCT01048554 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01048554 about?

NCT01048554 is a clinical study titled "Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System". 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...

What is the current status of trial NCT01048554?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2009-11. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01048554?

The interventions under investigation include: Bevacizumab (DRUG), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT01048554?

This trial is sponsored by Mt. Sinai Medical Center, Miami, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01048554's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01048554, the US trial registry maintained by the National Library of Medicine. NCT01048554 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.