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Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Primary Purpose

Central Nervous System Tumors, Lymphoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
temozolomide
topotecan hydrochloride
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Tumors focused on measuring primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 50-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic SGOT and SGPT ≤ 3 times upper limit of normal Bilirubin ≤ 2.0 mg/dL Renal Creatinine clearance > 40 mL/min Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic growth factors Chemotherapy See Disease Characteristics At least 6 weeks since prior nitrosoureas At least 2 weeks since prior methotrexate Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified Other 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 EXCLUSION CRITERA Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception. Known allergy to temozolomide or topotecan. Severe vomiting or other inability to administer medications orally. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Temozolomide, Topotecan

    Arm Description

    Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule

    Outcomes

    Primary Outcome Measures

    Rate of complete radiologic response (CR)

    Secondary Outcome Measures

    Median overall survival
    Failure-free survival
    Toxicity
    Overall response rate (CR and partial response)

    Full Information

    First Posted
    May 3, 2005
    Last Updated
    September 15, 2017
    Sponsor
    The Methodist Hospital Research Institute
    Collaborators
    Baylor College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00109798
    Brief Title
    Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
    Official Title
    Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sub-Investigator reloacted to another institution
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Methodist Hospital Research Institute
    Collaborators
    Baylor College of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Nervous System Tumors, Lymphoma
    Keywords
    primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Temozolomide, Topotecan
    Arm Type
    Experimental
    Arm Description
    Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
    Intervention Type
    Drug
    Intervention Name(s)
    temozolomide
    Other Intervention Name(s)
    Temodar
    Intervention Description
    Patient will take drug on day 1-5 of 28 day schedule
    Intervention Type
    Drug
    Intervention Name(s)
    topotecan hydrochloride
    Other Intervention Name(s)
    Topotecan
    Intervention Description
    Patient will have IV on days 2-6 on a 28-day schedule
    Primary Outcome Measure Information:
    Title
    Rate of complete radiologic response (CR)
    Time Frame
    July 2006
    Secondary Outcome Measure Information:
    Title
    Median overall survival
    Time Frame
    July 2006
    Title
    Failure-free survival
    Time Frame
    July 2006
    Title
    Toxicity
    Time Frame
    July 2006
    Title
    Overall response rate (CR and partial response)
    Time Frame
    July 2006

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 50-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic SGOT and SGPT ≤ 3 times upper limit of normal Bilirubin ≤ 2.0 mg/dL Renal Creatinine clearance > 40 mL/min Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic growth factors Chemotherapy See Disease Characteristics At least 6 weeks since prior nitrosoureas At least 2 weeks since prior methotrexate Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified Other 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 EXCLUSION CRITERA Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception. Known allergy to temozolomide or topotecan. Severe vomiting or other inability to administer medications orally. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pamela Z. New, MD
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

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