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

Brain Tumors Clinical Trial

Official title:

A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005812
• Other study ID #: D9812
• Secondary ID: DMS-9812NCI-G00-
• Status: Terminated
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: May 13, 2013
• Start date: January 2000
• Est. completion date: May 2004

Study information

• Verified date: May 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Brain Tumors
• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Leptomeningeal Metastases
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response	Response will be assessed clinically, cytologically, and radiographically.	Every 6 weeks	No
Secondary	Pharmacokinetics	Drug levels in cerebrospinal fluid assessed every 6 weeks	Every 6 weeks	Yes
Secondary	Survival		every 6 weeks	No
Secondary	Quality of Life	FACT-Br	Baseline, weekly during cycle 1, before each additional cycle	No