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Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
This study has been completed.

First Received on November 9, 2001.   Last Updated on February 26, 2011   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026494
  Purpose

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 Intervention Phase
Neoplasm Metastasis
 Drug: temozolomide
Drug: vinorelbine tartrate
 Phase I
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Vinorelbine Temozolomide Vinorelbine tartrate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose (phase I) assessed by NCI CTC at 2 months [ Designated as safety issue: Yes ]
  • Radiographic response (phase II) assessed by Macdonald criteria every 2 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: July 2001
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

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/mm^3
  • Platelet count at least 100,000/mm^3
  • 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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026494

Locations
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)
Investigators
Study Chair: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

ClinicalTrials.gov Identifier: NCT00026494     History of Changes
Other Study ID Numbers: CDR0000069035, MSKCC-01088A, NCI-G01-2025
Study First Received: November 9, 2001
Last Updated: February 26, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Temozolomide
Dacarbazine
Vinorelbine
Vinblastine
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 12, 2012



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