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Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

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ClinicalTrials.gov Identifier: NCT00004106
Recruitment Status : Terminated (Per Data Monitoring Committee given the poor/inadequate accrual.)
First Posted : January 27, 2003
Last Update Posted : June 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: temozolomide Phase 2

Detailed Description:


  • Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.
  • Determine the toxic effects of this drug in these patients.
  • Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
Study Start Date : May 1998
Primary Completion Date : April 2006
Study Completion Date : April 2006

Intervention Details:
    Drug: temozolomide
    Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks

Primary Outcome Measures :
  1. Response rate [ Time Frame: After every 2 cycles of therapy ]
    Disease response will be assessed using bi-dimensional measurements of lesions with clearly defined margins by medical photograph (skin lesion) or by radiological imaging (internal lesions).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed mycosis fungoides or Sezary syndrome

    • Stage IB-IVB disease
    • Must have failed at least one prior systemic therapy
    • Generalized erythroderma allowed
  • Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only

    • Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.2 mg/dL
  • SGOT or SGPT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine no greater than 2.0 mg/dL


  • No New York Heart Association class III or IV heart disease
  • No clinically significant peripheral venous insufficiency


  • HIV negative
  • No poorly controlled diabetes mellitus
  • No acute infection requiring IV antibiotics
  • No other medical condition that would prevent ingestion or absorption of oral medication
  • No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent growth factors or epoetin alfa


  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior topical steroids


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy for local control or palliation and recovered


  • Recovered from prior major surgery


  • No other concurrent investigational drugs

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 ClinicalTrials.gov identifier (NCT number): NCT00004106

United States, Connecticut
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8028
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004106     History of Changes
Other Study ID Numbers: NU FDA97H3
STU00010001 ( Other Identifier: Northwestern University IRB )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012

Keywords provided by Northwestern University:
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents