Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

NCT00004106 | Terminated Phase 2

• 4 other identifiers: NU FDA97H3NU-FDA97H3NCI-G99-1597STU00010001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Response rate

  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).

  After every 2 cycles of therapy

Interventions

temozolomide DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Yale Comprehensive Cancer Center at Yale University School of Medicine

New Haven, Connecticut, 06520-8028, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1998
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: June 6, 2012

Record last verified: 2012-05

Locations

US (3)