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

Phase 2

Terminated

• Conditions: Brain Tumors; Central Nervous System Tumors; Leptomeningeal Metastases
• Interventions: Drug: temozolomide

• Registration Number: NCT00005812
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temozolomide	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.

Primary Outcome Measures

Name	Time	Method
Objective Response	Every 6 weeks	Response will be assessed clinically, cytologically, and radiographically.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	Every 6 weeks	Drug levels in cerebrospinal fluid assessed every 6 weeks
Survival	every 6 weeks
Quality of Life	Baseline, weekly during cycle 1, before each additional cycle	FACT-Br

Trial Locations

Locations (1)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States