- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01164709
Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer
Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies
RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with bortezomib in treating patients with relapsed or progressive advanced hematologic cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- To assess the safety of nelfinavir mesylate in combination with bortezomib in patients with relapsed or progressive, advanced hematologic malignancies.
- To establish the phase II recommended dose of nelfinavir mesylate in these patients.
OUTLINE: This is a multicenter, dose-escalation study of nelfinavir mesylate.
Patients receive oral nelfinavir mesylate twice daily on days 1-21 and bortezomib IV on days 8, 11, 15, and 18 in course 1. Course 1 has a duration of 28 days. Beginning in course 2, patients receive oral nelfinavir mesylate twice daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for 2 courses. Patients with responding disease may continue to receive nelfinavir mesylate and bortezomib for up to 4 additional courses.
After completion of study treatment, patients are followed for 30 days.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
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Bern, Schweiz, CH-3010
- Inselspital Bern
-
Chur, Schweiz, CH-7000
- Kantonsspital Graubuenden
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Lausanne, Schweiz, CH-1011
- Centre Hospitalier Universitaire Vaudois
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St. Gallen, Schweiz, CH-9007
- Kantonsspital - St. Gallen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Diagnosed with advanced hematologic malignancies meeting the following criteria:
Multiple myeloma
- Received ≥ 2 lines of prior chemotherapy (induction chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant with or without maintenance therapy is considered one line of therapy)
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Diffuse large B-cell lymphoma
- Hodgkin lymphoma
- Mantle cell lymphoma
Mature T- and NK-cell neoplasms restricted to the following WHO-defined entities:
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Aggressive NK-cell leukemia
- Adult T-cell leukemia/lymphoma
- Extranodal NK/T-cell lymphoma (nasal type)
- Mycosis fungoides
- Sézary syndrome
- Primary CD30-positive T-cell lymphoproliferative disorders
- Primary cutaneous anaplastic large cell lymphoma
- Primary cutaneous gamma-delta T-cell lymphoma
- Peripheral T-cell lymphoma (not otherwise specified)
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma (ALK-positive/ALK-negative)
- Grade 3B follicular lymphoma
- Relapsed following or progressed during standard therapy
Meeting the following criteria:
- Standard intensive therapy is not feasible
- Current disease state for which there is no standard effective therapy
- Refused standard therapy where no curative option exists
Measurable disease, defined as the following:
- Myeloma: measurable serum monoclonal protein > 1 g/dL for IgG, or > 0.5 g/dL for IgA, IgM or IgD, or difference between involved and uninvolved free light chain levels in serum > 100 mg/L
- Lymphoma: must have ≥ 1 lesion measurable by CT (longest diameter ≥ 15 mm)
- Acute leukemia: ≥ 20% blasts in bone marrow or in peripheral blood (≥ 200/mL blasts in peripheral blood)
- No HIV-associated lymphoma
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³ (if bone marrow impairment, ≥ 20,000/mm^3)
- Hemoglobin > 80 g/L (if considered to be caused by the underlying hematologic malignancy or bone marrow impairment, > 80 g/L after transfusion)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (if suspected hemolysis, direct bilirubin ≤ 1.5 times ULN)
- ALT ≤ 2.5 times ULN
- Calculated creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Willing and capable to comply with an oral regimen
- Capable of understanding information given by the investigator on the trial
- Able to adhere and remain in geographic proximity to allow proper staging, treatment, and followup
- No other non-hematologic malignancy within the past 5 years, except adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
- No known chronic hepatitis B or C infection or known HIV infection
No serious underlying medical condition (at the judgment of the investigator) which would impair the ability of the patient to participate in the trial, including any of the following:
- Active autoimmune disease
- Uncontrolled diabetes
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric disorder
- No myocardial infarction within the past 6 months
- No polyneuropathy > grade 1 significantly interfering with activities of daily living or painful polyneuropathy
- No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 4 prior lines of chemotherapeutic regimens (induction chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant with or without maintenance therapy is considered one line of therapy)
- More than 30 days since prior treatment in a clinical trial
More than 30 days since prior and no concurrent chemotherapy or biologic agents
- For patients with acute leukemia, hydroxyurea may be given up to 48 hours before first administration of the trial treatment, and low dose cytarabine (up to 20 mg/m^2) and mitoxantrone up to 20 mg up to 14 days before first dosing
- At least 1 week since prior and no concurrent CYP3A4 modulators
- No concurrent other experimental drugs
- No concurrent radiotherapy
- No concurrent antineoplastic therapy with chemotherapeutic or biologic agents
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: bortezomib + nelfinavir
escalation 3 by 3 cohorts
|
Bortezomib i.v., day 8, 11, 15, 18; 1.3 mg/m2
Andra namn:
p.o., days 1 to 21; dose level: (625), 1250, 1875, or 2500 mg, 2x/d
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Dose limiting toxicity
Tidsram: during first cycle
|
during first cycle
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Objective response
Tidsram: during treatment
|
during treatment
|
Adverse events according to NCI CTCAE v.4.0
Tidsram: during treatment + 30 days
|
during treatment + 30 days
|
Samarbetspartners och utredare
Utredare
- Studiestol: Christoph Driessen, MD, Cantonal Hospital of St. Gallen
- Huvudutredare: Dagmar Hess, MD, Cantonal Hospital of St. Gallen
- Huvudutredare: Roger von Moos, MD, Kantonsspital Graubuenden
- Huvudutredare: Thomas Pabst, MD, University Hospital Inselspital, Berne
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium III vuxen diffust storcelligt lymfom
- stadium IV grad 3 follikulärt lymfom
- stadium IV vuxen diffust storcelligt lymfom
- återkommande follikulärt lymfom grad 3
- återkommande vuxen diffust storcelligt lymfom
- akut myeloid leukemi hos vuxna med 11q23 (MLL) abnormiteter
- akut myeloid leukemi hos vuxna med inv(16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(15;17)(q22;q12)
- akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- sekundär akut myeloid leukemi
- återkommande akut myeloid leukemi hos vuxna
- återkommande vuxen Hodgkin-lymfom
- stadium III grad 3 follikulärt lymfom
- stadium III mantelcellslymfom
- stadium IV mantelcellslymfom
- återkommande mantelcellslymfom
- stadium III vuxen Hodgkin lymfom
- stadium IV vuxen Hodgkin lymfom
- stadium III kutant T-cell non-Hodgkin lymfom
- stadium IV kutant T-cell non-Hodgkin lymfom
- återkommande kutant T-cell non-Hodgkin lymfom
- stadium III vuxen T-cellsleukemi/lymfom
- stadium IV vuxen T-cellsleukemi/lymfom
- återkommande vuxen T-cellsleukemi/lymfom
- angioimmunoblastiskt T-cellslymfom
- anaplastiskt storcelligt lymfom
- stadium III mycosis fungoides/Sezary syndrom
- stadium IV mycosis fungoides/Sezary syndrom
- återkommande mycosis fungoides/Sezary syndrom
- extranodalt NK/T-cellslymfom av typen vuxen nasal typ
- refraktärt multipelt myelom
- återkommande akut lymfatisk leukemi hos vuxna
- prolymfocytisk leukemi
- perifert T-cellslymfom
- T-cell stor granulär lymfocytleukemi
- aggressive NK-cell leukemia
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Neoplasmer
- Lymfom
- Multipelt myelom
- Neoplasmer, Plasmacell
- Leukemi
- Plasmacytom
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Antineoplastiska medel
- Proteashämmare
- HIV-proteashämmare
- Virala proteashämmare
- Bortezomib
- Nelfinavir
Andra studie-ID-nummer
- SAKK 65/08
- SWS-SAKK-65/08
- EU-21051
- SWS-SAKK-JC26866138LYM1005
- CDR0000681442 (Registeridentifierare: CDR0000681442)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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