At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
temozolomide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
- ✓Age 18 years or older
- ✓Karnofsky performance score ≥60
- ✓Histopathologically confirmed solid tumor malignancy; brain metastasis diagnosis does not require pathologic confirmation if clinical and neuroradiographic picture is typical
- ✓MRI or CT evidence of evaluable disease in the brain
Key exclusion· 5
- ✕Prior treatment with temozolomide, dacarbazine, or vinorelbine
- ✕Unrecovered acute toxicities from prior therapies
- ✕Leptomeningeal metastases or primary dural metastases
- ✕Poor medical risk due to nonmalignant systemic disease or acute infection requiring intravenous antibiotics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
In Brief
A Phase 2 clinical trial evaluating temozolomide and vinorelbine tartrate for Metastatic Cancer. Completed, enrolled 49 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer
CountriesUnited States
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2001
First PostedJan 2003
Primary CompletionApr 2008
TodayJul 2026
First PostedJan 27, 2003
Enrollment StartJul 1, 2001
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 23.4 years ago
Interventions
temozolomidedrug
vinorelbine tartratedrug