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Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00026494
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: temozolomide Drug: vinorelbine tartrate Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases (phase I accrual completed).
  • Determine the safety and feasibility of this treatment regimen in these patients.
  • Determine the efficacy of this treatment regimen, in terms of objective radiographic response and overall and progression-free survival, in these patients.

OUTLINE: This is a dose-escalation study of vinorelbine.

Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35 patients will be treated at that dose level.

Patients are followed every 3-4 months.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
Study Start Date : July 2001
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: temozolomide Drug: vinorelbine tartrate

Outcome Measures

Primary Outcome Measures :
  1. Radiographic Response Assessed by Macdonald Criteria Every 2 Months [ Time Frame: 2 years ]
    All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Age > or = 18 years.
  • Karnofsky performance score > or = 60.
  • Histopathologic confirmation of the diagnosis of a solid tumor malignancy. The brain metastasis diagnosis per se does not have to be pathologically confirmed if the clinical and neuro radiographic picture is typical.
  • MRI (or CT if the patient cannot undergo MRI) evidence of evaluable disease in the brain.
  • Absolute neutrophil count > or = 1,500/mm³. Platelet count > or = 100,000/mm³.
  • Hemoglobin > or = 10 g/dl.
  • BUN and serum creatinine both < 1.5 times upper limit of normal.
  • Total and direct bilirubin both < 1.5 times upper limit of normal.
  • SGOT and SGPT both < or = 3 times upper limit of normal.
  • Alkaline phosphatase < or = 2 times upper limit of normal.
  • At least two weeks must have elapsed from brain biopsy, craniotomy, or other surgery.
  • Life expectancy > or = 8 weeks.
  • Patient or their legal guardian or legal next-of-kin must provide written informed consent prior to patient's registration on study.
  • At least four weeks must have elapsed from previous external beam radiation therapy, or eight weeks from stereotactic radiosurgery.
  • Patients treated with radiosurgery should have evidence of progression at a distant site in the brain, or confirmation of tumor progression by biopsy or PET scan.


  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026494

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Northwestern Memorial Hospital
Study Chair: Lauren E. Abrey, MD Memorial Sloan Kettering Cancer Center
More Information

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00026494     History of Changes
Other Study ID Numbers: 01-088
First Posted: January 27, 2003    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators