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

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. Identifier: NCT00005812
Recruitment Status : Terminated (No objective response documented, protocol terminated after 12 patients.)
First Posted : January 27, 2003
Last Update Posted : May 14, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE June 2, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date May 14, 2013
Study Start Date  ICMJE January 2000
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
Objective Response [ Time Frame: Every 6 weeks ]
Response will be assessed clinically, cytologically, and radiographically.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005812 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Official Title  ICMJE A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
Brief Summary

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.

Detailed Description


  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Tumors
  • Central Nervous System Tumors
  • Leptomeningeal Metastases
Intervention  ICMJE Drug: temozolomide
Study Arms  ICMJE 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.
Intervention: Drug: temozolomide
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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 13, 2013)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00005812
Other Study ID Numbers  ICMJE D9812
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Thomas H. Davis, MD Norris Cotton Cancer Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date May 2013

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