Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Northwestern University

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Drug: temozolomide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004106

NCI-G99-1597

NU FDA97H3

STU00010001 (Other Identifier)

NU-FDA97H3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)