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Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

This study has been completed.
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center Identifier:
First received: November 9, 2001
Last updated: March 1, 2013
Last verified: March 2013

November 9, 2001
March 1, 2013
July 2001
April 2008   (final data collection date for primary outcome measure)
  • Maximum tolerated dose (phase I) assessed by NCI CTC at 2 months [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Radiographic response (phase II) assessed by Macdonald criteria every 2 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00026494 on Archive Site
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases

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.


  • 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.

Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Cancer
  • Drug: temozolomide
  • Drug: vinorelbine tartrate
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
Iwamoto FM, Omuro AM, Raizer JJ, Nolan CP, Hormigo A, Lassman AB, Gavrilovic IT, Abrey LE. A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases. J Neurooncol. 2008 Mar;87(1):85-90. Epub 2007 Nov 7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (final data collection date for primary outcome measure)


  • 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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
01-088, MSKCC-01088A, NCI-G01-2025
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • National Cancer Institute (NCI)
  • Northwestern Memorial Hospital
Study Chair: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP