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

NCT ID: NCT00005812

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2004-05-31

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

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.

Conditions

Brain Tumors; Central Nervous System Tumors; Leptomeningeal Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

Interventions

temozolomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas H. Davis, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Countries

United States

References

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

Reference Type: RESULT

Other Identifiers

DMS-9812

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1782

Identifier Type: -

Identifier Source: secondary_id

D9812

Identifier Type: -

Identifier Source: org_study_id