Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

NCT ID: NCT00004106

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2006-04-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

temozolomide

Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy M. Kuzel, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-FDA97H3

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1597

Identifier Type: -

Identifier Source: secondary_id

STU00010001

Identifier Type: OTHER

Identifier Source: secondary_id

NU FDA97H3

Identifier Type: -

Identifier Source: org_study_id