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Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma

This study has been terminated.
(No objective response documented, protocol terminated after 12 patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005812
First Posted: January 27, 2003
Last Update Posted: May 14, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.


Condition Intervention Phase
Brain Tumors Central Nervous System Tumors Leptomeningeal Metastases Drug: temozolomide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Objective Response [ Time Frame: Every 6 weeks ]
    Response will be assessed clinically, cytologically, and radiographically.


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Every 6 weeks ]
    Drug levels in cerebrospinal fluid assessed every 6 weeks

  • Survival [ Time Frame: every 6 weeks ]
  • Quality of Life [ Time Frame: Baseline, weekly during cycle 1, before each additional cycle ]
    FACT-Br


Enrollment: 12
Study Start Date: January 2000
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide

Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:

  • disease progression
  • intolerable toxicity
  • complete response - 2 full additional cycles
  • if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response.
Drug: temozolomide

Detailed Description:

OBJECTIVES:

  • Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.
  • Determine adverse events related to this regimen in this patient population.
  • Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.

OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.

Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.

Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Documented leptomeningeal metastases
  • Carcinomatous meningitis that is previously untreated or failed prior therapy OR
  • Lymphomatous meningitis
  • Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious
  • Age 18 and over
  • Karnofsky Performance Status 60-100%
  • Life expectancy of at least 6 weeks
  • Absolute neutrophil count greater than 1,500/μL
  • Platelet count greater than 100,000/μL
  • Creatinine no greater than 2.0 mg/dL
  • No congestive heart failure
  • No unstable angina
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir
  • No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting)
  • No uncontrolled infection
  • Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed
  • No other concurrent chemotherapy for other sites of disease
  • No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas
  • No prior radiotherapy to greater than 30% of bone marrow
  • Prior radiotherapy to the neuroaxis allowed
  • No concurrent radiotherapy for other sites of disease or for progressive disease
  • Recovered from any prior recent therapy
  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): NCT00005812


Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas H. Davis, MD Norris Cotton Cancer Center
  More Information

Publications:
Davis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00005812     History of Changes
Other Study ID Numbers: D9812
DMS-9812
NCI-G00-1782
First Submitted: June 2, 2000
First Posted: January 27, 2003
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:
leptomeningeal metastases
temozolomide

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Meningeal Carcinomatosis
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Meningeal Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents