Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

This study has been withdrawn prior to enrollment.
(Sub-Investigator reloacted to another institution)
Baylor College of Medicine
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
First received: May 3, 2005
Last updated: March 15, 2016
Last verified: March 2016

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 Intervention
Central Nervous System Tumors
Drug: temozolomide
Drug: topotecan hydrochloride

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma

Resource links provided by NLM:

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Rate of complete radiologic response (CR) [ Time Frame: July 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median overall survival [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
  • Failure-free survival [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: July 2006 ] [ Designated as safety issue: Yes ]
  • Overall response rate (CR and partial response) [ Time Frame: July 2006 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109798

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

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00109798     History of Changes
Other Study ID Numbers: BCM IRB#H-16155  CDR0000427313 
Study First Received: May 3, 2005
Last Updated: March 15, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016