- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00045695
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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-
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Illinois
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Hinsdale, Illinois, Stati Uniti, 60521
- Hinsdale Hematology Oncology Associates
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104-4283
- Abramson Cancer Center at the University of Pennsylvania
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
- Newly diagnosed or untreated with IgM ≥ 20 g/L OR
- Previously treated with IgM ≥ 5 g/L
- Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
Must have 1 or more of the following:
- Symptomatic lymphadenopathy
- Hepatomegaly and/or splenomegaly
- Anemia (i.e., hemoglobin < 11.0 g/dL)
- Hyperviscosity syndrome
- No other lymphoproliferative disease including transformed aggressive lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- No uncontrolled bacterial, fungal, or viral infection
- No pre-existing sensory or motor neurotoxicity grade 2 or greater
- No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
- No other serious illness or medical condition that would preclude study participation
- No unreasonable geographical limitations
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- See Disease Characteristics
- At least 12 weeks since prior rituximab (for patients who have progressed)
- At least 24 weeks since prior rituximab (for patients who have not progressed)
- No prior high-dose chemotherapy and stem cell transplantation
- No prior radioactive monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No more than 2 prior chemotherapy regimens
- The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- Single-agent rituximab not considered 1 prior regimen
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since prior plasmapheresis
- At least 4 weeks since prior investigational anticancer therapy
- No other concurrent investigational anticancer agents or therapies
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Response rate
Lasso di tempo: 4 years
|
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
|
4 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Toxicity
Lasso di tempo: 4 years
|
To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
|
4 years
|
Cytogenetics and genome profiling
Lasso di tempo: 4 years
|
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
|
4 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Christine I. Chen, MD, Princess Margaret Hospital, Canada
Pubblicazioni e link utili
Pubblicazioni generali
- Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.
- Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Neoplasie, plasmacellule
- Macroglobulinemia di Waldenstrom
- Agenti antineoplastici
- Bortezomib
Altri numeri di identificazione dello studio
- I152
- CAN-NCIC-IND152
- ECOG-JI152
- NCI-NCIC-152
- CDR0000257042 (Altro identificatore: PDQ)
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 .
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