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Temozolomide and Topotecan in Treating Patients With Primary CNS 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: NCT00109798
Recruitment Status : Withdrawn (Sub-Investigator reloacted to another institution)
First Posted : May 4, 2005
Last Update Posted : September 19, 2017
Baylor College of Medicine
Information provided by (Responsible Party):
The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Central Nervous System Tumors Lymphoma Drug: temozolomide Drug: topotecan hydrochloride Not Applicable

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
Study Start Date : March 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Arm Intervention/treatment
Experimental: Temozolomide, Topotecan
Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
Drug: temozolomide
Patient will take drug on day 1-5 of 28 day schedule
Other Name: Temodar

Drug: topotecan hydrochloride
Patient will have IV on days 2-6 on a 28-day schedule
Other Name: Topotecan

Primary Outcome Measures :
  1. Rate of complete radiologic response (CR) [ Time Frame: July 2006 ]

Secondary Outcome Measures :
  1. Median overall survival [ Time Frame: July 2006 ]
  2. Failure-free survival [ Time Frame: July 2006 ]
  3. Toxicity [ Time Frame: July 2006 ]
  4. Overall response rate (CR and partial response) [ Time Frame: July 2006 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria


  • Histologically confirmed primary CNS lymphoma at initial diagnosis
  • Measurable tumor by radiography
  • Failed* OR is not a candidate for first-line high-dose systemic methotrexate-based chemotherapy with or without radiotherapy NOTE: *Failure is defined as relapse, progression, or failure to achieve a complete response



  • 18 and over

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL


  • SGOT and SGPT ≤ 3 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine clearance > 40 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known allergy to temozolomide or topotecan
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
  • No other major medical illness or psychiatric impairment that would preclude study participation


Biologic therapy

  • No concurrent prophylactic growth factors


  • See Disease Characteristics
  • At least 6 weeks since prior nitrosoureas
  • At least 2 weeks since prior methotrexate

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Recovered from all prior therapy
  • At least 4 weeks since prior non-nitrosourea cytotoxic drugs (except methotrexate)
  • At least 4 weeks since prior systemic investigational agents
  • At least 2 weeks since prior non-cytotoxic antitumor drugs
  • No other concurrent antitumor therapy


  1. Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception.
  2. Known allergy to temozolomide or topotecan.
  3. Severe vomiting or other inability to administer medications orally.
  4. Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109798

Sponsors and Collaborators
The Methodist Hospital System
Baylor College of Medicine
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Study Chair: Pamela Z. New, MD Baylor College of Medicine

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Responsible Party: The Methodist Hospital System Identifier: NCT00109798     History of Changes
Other Study ID Numbers: BCM IRB#H-16155
CDR0000427313 ( Other Identifier: Principal Investigator )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Methodist Hospital System:
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors