Lymphoma
Conditions
Keywords
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
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.
Detailed description
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.
Interventions
DRUGtemozolomide
Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 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). |
Countries
United States
Outcome results
None listed