Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

This study has been terminated.
(Per Data Monitoring Committee given the poor/inadequate accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004106
First received: December 10, 1999
Last updated: May 31, 2012
Last verified: May 2012

December 10, 1999
May 31, 2012
May 1998
April 2006   (final data collection date for primary outcome measure)
Response rate [ Time Frame: After every 2 cycles of therapy ] [ Designated as safety issue: No ]
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).
Not Provided
Complete list of historical versions of study NCT00004106 on ClinicalTrials.gov Archive Site
Not Provided
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Not Provided
 
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: temozolomide
Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004106
NU FDA97H3, NU-FDA97H3, NCI-G99-1597, STU00010001
Not Provided
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP