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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
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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).


Enrollment: 29
Study Start Date: May 1998
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: temozolomide
    Temozolomid will be administered orally at a dose of 150mg/m2/day for 5 days for a total of 4 weeks
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004106

Locations
United States, Connecticut
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8028
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004106     History of Changes
Other Study ID Numbers: NU FDA97H3, NU-FDA97H3, NCI-G99-1597, STU00010001
Study First Received: December 10, 1999
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Syndrome
Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014