- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00052572
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.
Secondary
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive ixabepilone IV over 1 hour weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1-1.5 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Vermont
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center at University of Vermont
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
Chronic lymphocytic leukemia
- Absolute lymphocytosis greater than 5,000/mm^3
- B-cell phenotype (CD 19, 20, or 23 positive) with more than 30% bone marrow lymphocytes
- B-cell small lymphocytic lymphoma
- Marginal zone B-cell lymphoma
- Grade I-III follicle center cell lymphoma
- Waldenstrom's macroglobulinemia
- Mantle cell lymphoma
At least 1 unidimensionally measurable lesion for patients with non-Hodgkin's lymphoma
- At least 2 cm by conventional techniques
No active brain metastases
- Treated CNS disease allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 if there is lymphomatous involvement of the bone marrow)
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement)
Renal
- Creatinine ≤ 2 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No history of orthostatic hypotension
- No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 3 months
- No New York Heart Association class III or IV congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension requiring manipulation of antihypertensive medications
No evidence of any of the following by echocardiogram:
- Acute ischemia
Significant conduction abnormality
- Bifascicular block
- 2^nd- or 3^rd-degree atrioventricular block
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other immunodeficiency
- No known severe hypersensitivity reaction to agents containing Cremophor EL
- No ongoing or active infection
- Febrile episodes up to 38.5° Celsius allowed in the absence of infection
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No preexisting grade II or greater sensory neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior monoclonal antibodies (unless there is clearly documented evidence of disease progression after therapy)
- At least 3 months since prior radioimmunotherapy
- No prior allogeneic bone marrow transplantation
Chemotherapy
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered
No more than 4 prior chemotherapy regimens (including high-dose chemotherapy [HDC] for patients with relapsed disease > 100 days after completion of HDC)
- Cytoreduction plus HDC is considered 1 chemotherapy regimen
- No other concurrent chemotherapy
Endocrine therapy
- At least 7 days since prior steroids
Radiotherapy
- More than 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery
Other
- Use of antibiotics for marginal zone lymphoma does not count as a prior therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Sikkerhed
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Effektivitet
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Sekundære resultatmål
Resultatmål |
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Progressionsfri overlevelse
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Mean and median duration of response
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Mean and median duration of progression-free and overall survival
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Probability of polymerase chain reaction negativity after treatment
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- B-celle kronisk lymfatisk leukæmi
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende marginal zone lymfom
- tilbagevendende lille lymfocytisk lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- tilbagevendende kappecellelymfom
- refraktær kronisk lymfatisk leukæmi
- Waldenström makroglobulinæmi
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000258542
- MSKCC-02046
- NCI-5342
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ixabepilone
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R-PharmAfsluttet
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Bristol-Myers SquibbAfsluttet
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R-PharmGlaxoSmithKlineAfsluttetLokalt avanceret eller metastatisk brystkræftForenede Stater, Italien, Australien
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R-PharmAfsluttetIkke-småcellet lungekræft (NSCLC)Japan
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R-PharmAfsluttetAvanceret/metastatisk ikke-småcellet lungekræftTyskland, Korea, Republikken, Den Russiske Føderation, Taiwan, Australien, Italien, Frankrig, Forenede Stater, Argentina, Spanien