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- Klinische proef NCT00227513
Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Bortezomib in Patients With Advanced Malignancies
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of vorinostat (SAHA) and bortezomib in patients with metastatic or unresectable solid tumors.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics and antitumor activity of this regimen in these patients.
II. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral vorinostat (SAHA) twice daily on days 1-14 in step A. Patients receive oral vorinostat (SAHA) twice daily on days 1-4 and 8-11 in Step B and bortezomib IV over 3-5 seconds on days 2, 5, 9, and 12 during the first course and on days 1, 4, 8, and 11 during subsequent courses in both steps A and B. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 6 additional patients receive bortezomib at the MTD. Subsequent cohorts of 3-6 patients receive escalating doses of SAHA until the MTD of that drug is determined.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Hospital and Clinics
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically confirmed malignancy, metastatic or unresectable disease
- Standard curative or palliative measures do not exist OR are no longer effective
- Measurable or evaluable disease
- No known brain metastases
- ECOG 0-2 OR Karnofsky 60-100%
- Life expectancy > 12 weeks
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No history of myocardial infarction
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No severe pulmonary disease requiring oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 28 days after study participation
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or agents
- No pre-existing neuropathy ≥ grade 2
- No uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior radiotherapy to > 25% of bone marrow
- At least 4 weeks since prior radiotherapy and recovered
- At least 2 weeks since prior valproic acid
- No prior bortezomib
- No concurrent enzyme-inducing anticonvulsant agents
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Arm I
Patients receive oral vorinostat (SAHA) twice daily on days 1-14 in step A. Patients receive oral vorinostat (SAHA) twice daily on days 1-4 and 8-11 in Step B and bortezomib IV over 3-5 seconds on days 2, 5, 9, and 12 during the first course and on days 1, 4, 8, and 11 during subsequent courses in both steps A and B. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 6 additional patients receive bortezomib at the MTD. Subsequent cohorts of 3-6 patients receive escalating doses of SAHA until the MTD of that drug is determined. |
Mondeling gegeven
Andere namen:
IV gegeven
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Maximaal getolereerde dosis (MTD) bepaald op basis van dosisbeperkende toxiciteiten (DLT's) ingedeeld volgens Common Terminology Criteria for Adverse Events versie 3.0 (CTCAE v3.0)
Tijdsspanne: 21 dagen
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21 dagen
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Frequency and severity of toxicity incidents assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Tijdsspanne: Up to 5 years
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Up to 5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Anti-tumor activity by tumor measurements assessed by RECIST
Tijdsspanne: Up to 5 years
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Up to 5 years
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Peak plasma concentration (Cmax) of SAHA
Tijdsspanne: Days 1, 2, and 12
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Days 1, 2, and 12
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Time to SAHA Cmax (Tmax)
Tijdsspanne: Days 1, 2, and 12
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Days 1, 2, and 12
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Clearance of SAHA
Tijdsspanne: Days 1, 2, and 12
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Days 1, 2, and 12
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NCI-2009-00097 (Register-ID: CTRP (Clinical Trial Reporting Program))
- P30CA014520 (Subsidie/contract van de Amerikaanse NIH)
- U01CA062491 (Subsidie/contract van de Amerikaanse NIH)
- 6910 (Andere identificatie: CTEP)
- CDR0000441195
- H-2005-0205
- CO 04906 (Andere identificatie: University of Wisconsin Hospital and Clinics)
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Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCBeëindigd
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Virginia Commonwealth UniversityIngetrokken
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Johns Hopkins All Children's HospitalBeëindigdTumoren van het centrale zenuwstelselVerenigde Staten
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National Center for Tumor Diseases, HeidelbergMerck Sharp & Dohme LLC; University Hospital HeidelbergVoltooid
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Merck Sharp & Dohme LLCNiet meer beschikbaar
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Medical University of GrazBeëindigdLeiomyosarcoom | Endometriale stromale tumoren | Carcinosarcomen BaarmoederOostenrijk
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German Center for Neurodegenerative Diseases (DZNE)University Hospital, Bonn; University of GöttingenBeëindigd
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Kanazawa UniversityOnbekendNiet-kleincellig longcarcinoomJapan