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A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Cancer

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Trial Information

A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With 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

- 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

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (phase I) assessed by NCI CTC at 2 months

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2001

Completion Date:

April 2008

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611