Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

This study has been withdrawn prior to enrollment.
(Sub-Investigator reloacted to another institution)
Sponsor:
Information provided by (Responsible Party):
Pamela New, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00109798
First received: May 3, 2005
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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 Phase
Central Nervous System Tumors
Lymphoma
Drug: temozolomide
Drug: topotecan hydrochloride
Phase 2

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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
Investigators
Study Chair: Pamela Z. New, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Pamela New, MD, Pamela New, M.D., The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00109798     History of Changes
Other Study ID Numbers: CDR0000427313, BCM-H-16155
Study First Received: May 3, 2005
Last Updated: November 20, 2012
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:
Lymphoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Temozolomide
Dacarbazine
Topotecan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014