Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NU-FDA97H3 NCI-G99-1597, NCT00004106

Objectives

1. Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.
2. Determine the toxic effects of this drug in these patients.
3. Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.

Entry 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

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

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/mm³
• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 12-37 patients will be accrued for this study within 2 years.

Outcomes

Response rate
Toxic effects
Correlation of pretreatment AFT activity in tumor cells with response

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Timothy Kuzel, MD, Protocol chair		Ph: 312-695-6180

Registry Information
Official Title		Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
Trial Start Date		1999-08-31
Registered in ClinicalTrials.gov		NCT00004106
Date Submitted to PDQ		1999-09-13
Information Last Verified		2005-10-18
NCI Grant/Contract Number		P30-CA60553

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