Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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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 |
- 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) |
-
Drug: temozolomide
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 |
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| 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 | |
| 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous |
Lymphoma, T-Cell Lymphoma, Non-Hodgkin Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013