Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00026494
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Cancer

Eligibility Criteria

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

Interventions

Study Details

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 Dates

Start date
Jul 31, 2001
Status verified
Dec 2015
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

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

Arms

  • Experimental: Temozolomide and Vinorelbine
    Patients will be treated with vinorelbine on days 1 and 8 of each cycle; temozolomide will be administered on days 1 to 7 and 15 to 21 of each cycle. The dose level of temozolomide will be given at a dose of 150 mg/m2/day. A cycle will be defined as 28 days of treatment.

Primary Outcome Measure

Radiographic Response Assessed by Macdonald Criteria Every 2 Months [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-3013-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-

Find similar trials in Chicago, IL

By research site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University· Chicago, ILMemorial Sloan-Kettering Cancer Center· New York, NY

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