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Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
11 december 2019 bijgewerkt door: University of Wisconsin, Madison
A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
The investigators want to find out if the drugs Velcade and temsirolimus given together are effective in treating cancer.
Velcade and temsirolimus are each FDA approved individually for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and temsirolimus for renal cell carcinoma) but are not currently approved in combination for B-cell non-Hodgkin lymphoma.
The investigators are trying to find out if giving these 2 drugs together will improve the period of time that the patient's cancer is stopped or slowed from growing and causing symptoms.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
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Wisconsin
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Green Bay, Wisconsin, Verenigde Staten, 54143
- Aurora Baycare Medical Center-GreenBay
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Green Bay, Wisconsin, Verenigde Staten, 54301
- St Vincent Regional Cancer Center CCOP
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Green Bay, Wisconsin, Verenigde Staten, 54313
- Bellin Memorial Hospital, Inc
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Gunderson Lutheran Health System
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Madison, Wisconsin, Verenigde Staten, 53715
- UW Health Oncology- 1 S Park
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Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Cancer Center
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Marinette, Wisconsin, Verenigde Staten
- Aurora BayCare Medical Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Clinic
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53211
- Columbia St Mary's, Inc
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Sheboygan, Wisconsin, Verenigde Staten, 53081
- Aurora Sheboygan Memorial Medical Center
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Summit, Wisconsin, Verenigde Staten, 53066
- Aurora Medical Center in Summit
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Two Rivers, Wisconsin, Verenigde Staten, 54241
- Aurora Medical Center in Two Rivers
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Waukesha, Wisconsin, Verenigde Staten, 53188
- Waukesha Memorial Hospital
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Wausau, Wisconsin, Verenigde Staten, 54401
- Aspirus Wausau Hospital
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Wauwatosa, Wisconsin, Verenigde Staten, 53226
- Aurora Health Care Metro, Inc.
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Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
- UW Cancer Center-Riverview
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Relapsed or refractory B-cell non-Hodgkin lymphoma which includes: diffuse large B-cell lymphoma; primary mediastinal large B-cell lymphoma; follicular lymphoma (grade 1, 2 or 3); mantle cell lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; lymphoplasmacytic lymphoma; B-cell lymphoblastic lymphoma; or Burkitt lymphoma. "Grey-zone" lymphomas must be approved by the Wisconsin Oncology Network (WON) Study Chair or Principal Investigator prior to enrollment.
- At least one measurable tumor mass (>1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation.
- Documented relapse or progression following prior antineoplastic therapy.
- No clinical or documented radiographic evidence of central nervous system lymphoma.
- Eastern Cooperative Oncology Group [ECOG] performance status of 0-2.
- The following clinical laboratory values within 14 days prior to enrollment:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells / L
- Platelets ≥ 100 x 109 cells / L
- Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3X the upper limit of normal (ULN)
- Total bilirubin ≤ 2X the upper limit of normal (ULN).
- Calculated creatinine clearance ≥40 mL/min (using the Cockcroft-Gault equation).
- Female subjects must be either post-menopausal for at least 1 year or surgically sterilized, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of Velcade, or agree to completely abstain from heterosexual intercourse.
- Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
Exclusions:
- Antineoplastic, experimental, or radiation therapy within 14 days prior to enrollment, or 21 days prior to Day 1 of Cycle 1.
- Radioimmunoconjugates within 10 weeks of Day 1 of Cycle 1.
- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or any prior history of allogeneic stem cell transplant.
- Platelet transfusion within 7 days of Day 1 of Cycle 1.
- Ongoing therapy with glucocorticoids. Prednisone ≤15 mg per day or its equivalent is allowed.
- Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient has hypersensitivity to Velcade, boron or mannitol.
- Female subjects that are pregnant or breast-feeding.
- Serious medical or psychiatric illness that is likely to interfere with participation
- Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Prior therapy with both Velcade and temsirolimus. Patients who have previously been treated with either Velcade or temsirolimus (but not both) are eligible.
- Radiation therapy within 3 weeks before randomization.
- Patients must not be taking the following strong CyP3A inducers at study entry: phenytoin, phenobarbital, rifampin, carbamazepin, rifabutin, rifampicin, a one week washout period is required.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
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: Velcade plus Temsirolimus
Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. |
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Andere namen:
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate
Tijdsspanne: Up to 60 months
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The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy.
ORR is the sum of patients with a Complete Response and Partial Response to therapy.
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Up to 60 months
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Progression Free Survival
Tijdsspanne: Up to 60 months
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The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
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Up to 60 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Safety of This Regimen
Tijdsspanne: Up to 36 months
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Safety of the regimen will be measured by frequency and severity of adverse events.
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Up to 36 months
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Complete Response Rate
Tijdsspanne: Up to 60 months
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The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
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Up to 60 months
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Tolerability of the Regimen
Tijdsspanne: Up to 36 months
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Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
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Up to 36 months
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Duration of Response
Tijdsspanne: Up to 60 months
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Duration of Response is how long a response to therapy is held before a subject has progressive disease.
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Up to 60 months
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Overall Survival
Tijdsspanne: Up to 60 months
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Length of time from enrollment until death.
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Up to 60 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Brad S Kahl, MD, Universtity of Wisconsin- Madison
- Studie stoel: Timothy S Fenske, MD, Medical College of Wisconsin
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2011
Primaire voltooiing (Werkelijk)
1 oktober 2013
Studie voltooiing (Werkelijk)
1 juni 2014
Studieregistratiedata
Eerst ingediend
20 januari 2011
Eerst ingediend dat voldeed aan de QC-criteria
21 januari 2011
Eerst geplaatst (Schatting)
24 januari 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 december 2019
Laatste update ingediend die voldeed aan QC-criteria
11 december 2019
Laatst geverifieerd
1 juli 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Lymfoom, non-Hodgkin
- Fysiologische effecten van medicijnen
- Anti-infectieuze middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antibacteriële middelen
- Antibiotica, antineoplastiek
- Antischimmelmiddelen
- Bortezomib
- Sirolimus
Andere studie-ID-nummers
- HO10407
- A534260 (Andere identificatie: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Andere identificatie: UW Madison)
- H-2010-0393 (Andere identificatie: IRB)
- NCI-2011-00647 (Register-ID: NCI Trial ID)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Marker Therapeutics, Inc.WervingNon-Hodgkin lymfoom | Non-Hodgkin-lymfoom, volwassene | Non-Hodgkin-lymfoom, refractair | Non-Hodgkin-lymfoom, recidiverendVerenigde Staten
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Stanford UniversityNational Institutes of Health (NIH); AmgenVoltooidLymfoom, non-Hodgkin | Lymfomen: Non-Hodgkin | Lymfomen: non-Hodgkin perifere T-cel | Lymfomen: non-Hodgkin huidlymfoom | Lymfomen: non-Hodgkin diffuse grote B-cel | Lymfomen: non-Hodgkin folliculair / indolente B-cel | Lymfomen: non-Hodgkin-mantelcel | Lymfomen: non-Hodgkin marginale zone | Lymfomen...Verenigde Staten
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Chongqing Precision Biotech Co., LtdWervingNon-Hodgkin lymfoom | Refractair non-Hodgkin-lymfoom | Recidiverend non-Hodgkin-lymfoomChina
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Memorial Sloan Kettering Cancer CenterWervingNon-Hodgkin lymfoom | Non-Hodgkin-lymfoom, recidiverend | Non-Hodgkin-lymfoom refractairVerenigde Staten
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National Cancer Institute (NCI)WervingRefractair B-cel non-Hodgkin-lymfoom | Refractair T-cel non-Hodgkin-lymfoom | Recidiverend B-cel non-Hodgkin-lymfoom | Terugkerend getransformeerd non-Hodgkin-lymfoom | Recidiverend non-Hodgkin-lymfoom | Refractair non-Hodgkin-lymfoom | Recidiverend T-cel non-Hodgkin-lymfoom | Recidiverend primair... en andere voorwaardenVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actief, niet wervendRefractair Hodgkin-lymfoom | Refractair B-cel non-Hodgkin-lymfoom | Refractair T-cel non-Hodgkin-lymfoom | Ontvanger van hematopoëtische celtransplantatieVerenigde Staten