Clinical trial NCT00004106: Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Official title: Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response rate
timeFrame: After every 2 cycles of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center at Yale University School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Timothy M. Kuzel, MD
role: STUDY_CHAIR
References: