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

Inclusion Criteria

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