Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Not Applicable

Withdrawn

• Conditions: Central Nervous System Tumors; Lymphoma
• Interventions: Drug: temozolomide; Drug: topotecan hydrochloride

• Registration Number: NCT00109798
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan.

Secondary

* Determine the median and failure-free survival of patients treated with this regimen.

* Determine the toxicity of this regimen in these patients.

* Determine the overall response rate in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oral temozolomide once daily on days 1-5 and topotecan IV over 30 minutes once daily on days 2-6. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 6-25 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-05-03
• Study First Submitted QC: 2005-05-03
• Study First Posted: 2005-05-04
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temozolomide, Topotecan	topotecan hydrochloride	Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
Temozolomide, Topotecan	temozolomide	Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule

Primary Outcome Measures

Name	Time	Method
Rate of complete radiologic response (CR)	July 2006

Secondary Outcome Measures

Name	Time	Method
Failure-free survival	July 2006
Toxicity	July 2006
Median overall survival	July 2006
Overall response rate (CR and partial response)	July 2006