Clinical trial · Interventional
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
NCT00004106CI-TRIAL-00007091terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per Data Monitoring Committee given the poor/inadequate accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- After every 2 cycles of therapy
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.