- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
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Vermont
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Burlington, Vermont, Stati Uniti, 05401-3498
- Vermont Cancer Center at University of Vermont
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Sicurezza
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Efficacia
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Misure di risultato secondarie
Misura del risultato |
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Sopravvivenza libera da progressione
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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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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Leucemia linfatica cronica a cellule B
- linfoma follicolare ricorrente di grado 3
- linfoma follicolare ricorrente di grado 1
- linfoma follicolare ricorrente di grado 2
- linfoma ricorrente della zona marginale
- piccolo linfoma linfocitico ricorrente
- linfoma a cellule B della zona marginale extranodale del tessuto linfoide associato alla mucosa
- linfoma a cellule B della zona marginale nodale
- linfoma splenico della zona marginale
- linfoma mantellare ricorrente
- leucemia linfatica cronica refrattaria
- Macroglobulinemia di Waldenstrom
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000258542
- MSKCC-02046
- NCI-5342
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .