Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	MSKCC-01088A NCI-G01-2025, NCT00026494

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed solid tumor with metastases to the brain
• Evaluable disease in brain by MRI or CT scan

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior biologic therapy or immunotherapy and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy and recovered
• No prior temozolomide, dacarbazine, or vinorelbine
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior external beam radiotherapy
• At least 8 weeks since prior stereotactic radiosurgery
• Concurrent focal radiotherapy for progressive bony disease allowed if brain metastases are stable or responding

Surgery:

• At least 2 weeks since prior brain biopsy, craniotomy, or other surgery

Other:

• Recovered from all prior therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 3 times ULN
• Alkaline phosphatase no greater than 2 times ULN

Renal:

• Creatinine less than 1.5 times ULN
• BUN less than 1.5 times ULN

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No AIDS-related illness
• No nonmalignant systemic disease
• No psychiatric condition that would preclude study
• No acute infection requiring IV antibiotics
• No frequent vomiting or medical condition that would preclude oral medication intake (i.e., partial bowel obstruction)

Expected Enrollment

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.

Outcomes

Maximum tolerated dose (phase I) assessed by NCI CTC at 2 months
Radiographic response (phase II) assessed by Macdonald criteria every 2 months

Overall survival
Progression-free survival

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.

Iwamoto FM, Omuro AM, Raizer JJ, et al.: A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases. J Neurooncol 87 (1): 85-90, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Lauren Abrey, MD, Protocol chair		Ph: 212-639-5122; 800-525-2225 Email: abreyl@mskcc.org

Registry Information
Official Title		A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases
Trial Start Date		2001-07-10
Trial Completion Date		2008-04-08
Registered in ClinicalTrials.gov		NCT00026494
Date Submitted to PDQ		2001-10-01
Information Last Verified		2009-12-15
NCI Grant/Contract Number		CA08748

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