Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR WHO 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: 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 Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No clinically significant peripheral venous insufficiency Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent growth factors or epoetin alfa Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior topical steroids Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy for local control or palliation and recovered Surgery: Recovered from prior major surgery Other: No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | 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). | After every 2 cycles of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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