Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Cancer

In brief

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.

Key facts

Study ID

NCT00026494

Run by

Memorial Sloan Kettering Cancer Center

People needed

49

Starts

2001-07-01

Expected to finish

2008-04-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previous treatment with temozolomide, dacarbazine or vinorelbine.
• Patients who have not recovered from all acute toxicities of prior therapies.
• Patients with evidence of leptomeningeal metastases or primary dural metastases.
• Patients who are poor medical risks because of nonmalignant systemic disease, as well as those with acute infection requiring treatment with intravenous antibiotics.
• Patients whose psychiatric condition would, in the judgment of the principal investigator, make it unlikely that they could adhere to the requirements of the protocol.

Where it is running

• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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