Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

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: 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

December 10, 1999
January 27, 2003
June 6, 2012
May 1998
April 2006   (Final data collection date for primary outcome measure)
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).
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Complete list of historical versions of study NCT00004106 on Archive Site
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Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome

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.


  • 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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: temozolomide
Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2006
April 2006   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
STU00010001 ( Other Identifier: Northwestern University IRB )
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP