- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00538187
Obatoclax and Bortezomib in Treating Patients With Aggressive Relapsed or Recurrent Non-Hodgkin Lymphoma
Phase I Study of GX15-070 (NSC # 729280) and Bortezomib in Aggressive Relapsed/Recurrent Non-Hodgkin's Lymphoma
Panoramica dello studio
Stato
Condizioni
- Linfoma diffuso a grandi cellule dell'adulto ricorrente
- Linfoma follicolare ricorrente di grado 1
- Linfoma follicolare ricorrente di grado 2
- Linfoma follicolare ricorrente di grado 3
- Linfoma Mantellare Ricorrente
- Linfoma ricorrente della zona marginale
- Piccolo linfoma linfocitico ricorrente
- Linfoma non Hodgkin dell'adulto
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose of obatoclax mesylate when administered with bortezomib in patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.
II. To describe the toxicities of this regimen at each dose studied in these patients.
III. To characterize the pharmacokinetic behavior of this regimen in these patients.
IV. To obtain preliminary information regarding the effect of obatoclax mesylate on several apoptotic regulatory pathways.
V. To document all clinical responses in these patients to this regimen.
OUTLINE: This is a multicenter study.
PHASE I: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on days 1, 8, 15, and 22.
Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity. Pharmacokinetic evaluations of obatoclax mesylate are conducted in all patients during the first course.
PHASE II: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on days 1, 8, 15, and 22 at the maximum tolerated dose determined in phase I.
Treatment repeats every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 26 weeks.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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California
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Duarte, California, Stati Uniti, 91010
- City of Hope Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Histologically or cytologically confirmed relapsed or refractory non-Hodgkin lymphoma for which standard curative or palliative measures do not exist or are no longer effective, including any of the following subtypes:
- Follicular grade I, II, or III lymphoma
- Marginal zone lymphoma
- Mantle cell lymphoma
- Diffuse large B cell lymphoma
- Small lymphocytic lymphoma
Must have had at least one prior chemotherapeutic regimen:
- Steroids or rituximab alone or local radiotherapy do not count as regimens
- Tositumomab or ibritumomab tiuxetan allowed as regimens
- Clear evidence of disease progression or lack of response after the most recent therapy, including rituximab or local radiotherapy, is required
- At least 3 months since prior autologous stem cell transplantation and relapsed (>= 1 year since prior allogeneic transplantation and relapsed) and no active related infections (i.e., fungal or viral)
- In the case of allogeneic transplantation relapse, there should be no active acute graft-versus-host disease (GVHD) of any grade and no chronic GVHD other than mild skin, oral, or ocular GVHD not requiring systemic immunosuppression
- No known active brain metastases, other neurological disorders/dysfunction or history of seizure disorder, or other neurological dysfunction
- Karnofsky performance status 60-100%
- Life expectancy > 3 months
- Total bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine normal or creatinine clearance >= 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for 3 months after the last dose of obatoclax mesylate
- At least 4 weeks since prior radiotherapy
- More than 2 days since prior steroids
- More than 2 weeks since prior low-dose chlorambucil
- WBC >= 3,000/mm^3
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- At least 2 weeks since prior valproic acid
Exclusion Criteria:
Uncontrolled concurrent medical condition or illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia including QTc > 450 msec
- Patients who are intolerant or refractory to prior treatment with bortezomib (refractory is defined as no response to prior treatment with bortezomib)
- Chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- Rituximab within the past 3 months (unless there is evidence of progression)
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Other concurrent investigational agents
- Combination antiretroviral therapy for HIV-positive patients
- No history of allergic reactions attributed to bortezomib, polyethylene glycol (PEG 300), or polysorbate 20
- No psychiatric illness or social situation that would limit compliance with study requirements
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Treatment (obatoclax mesylate, bortezomib)
Patients will receive a 3-hour infusion of obatoclax and an infusion of bortezomib once a week for 4 weeks
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Dato IV
Altri nomi:
studio correlativo
Altri nomi:
studio correlativo
Dato IV
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Maximum tolerated dose of obatoclax mesylate when administered with bortezomib
Lasso di tempo: 35 days
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Defined as the highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity.
Graded according to the NCI CTCAE, Version 3.0.
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35 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Toxicity as assessed by NCI CTCAE version 3.0
Lasso di tempo: Up to 26 weeks after completion of study treatment
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Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity and nadir or maximum values for the laboratory measures, time of onset (i.e.
course number), duration, and reversibility or outcome.
Tables will be created to summarize these toxicities and side effects by dose and by course.
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Up to 26 weeks after completion of study treatment
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Pharmacokinetics of obatoclax mesylate when administered with bortezomib
Lasso di tempo: Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours
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Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Joseph Tuscano, City of Hope Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (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
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Attributi della malattia
- Leucemia, linfoide
- Leucemia
- Leucemia, cellule B
- Linfoma, cellule B
- Linfoma
- Linfoma, follicolare
- Linfoma, a grandi cellule B, diffuso
- Ricorrenza
- Linfoma non Hodgkin
- Linfoma, cellule del mantello
- Leucemia, linfocitica, cronica, cellule B
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Bortezomib
- Obatoclax
Altri numeri di identificazione dello studio
- NCI-2009-00253
- U01CA062505 (Sovvenzione/contratto NIH degli Stati Uniti)
- PHI-58
- CDR0000566357
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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