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Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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).

Outcome Time Frame:

After every 2 cycles of therapy

Safety Issue:

No

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU FDA97H3

NCT ID:

NCT00004106

Start Date:

May 1998

Completion Date:

April 2006

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611