Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
11 december 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
-
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Wisconsin
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Green Bay, Wisconsin, Förenta staterna, 54143
- Aurora Baycare Medical Center-GreenBay
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Green Bay, Wisconsin, Förenta staterna, 54301
- St Vincent Regional Cancer Center CCOP
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Green Bay, Wisconsin, Förenta staterna, 54313
- Bellin Memorial Hospital, Inc
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La Crosse, Wisconsin, Förenta staterna, 54601
- Gunderson Lutheran Health System
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Madison, Wisconsin, Förenta staterna, 53715
- UW Health Oncology- 1 S Park
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Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Cancer Center
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Marinette, Wisconsin, Förenta staterna
- Aurora BayCare Medical Center
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53211
- Columbia St Mary's, Inc
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Sheboygan, Wisconsin, Förenta staterna, 53081
- Aurora Sheboygan Memorial Medical Center
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Summit, Wisconsin, Förenta staterna, 53066
- Aurora Medical Center in Summit
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Two Rivers, Wisconsin, Förenta staterna, 54241
- Aurora Medical Center in Two Rivers
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Waukesha, Wisconsin, Förenta staterna, 53188
- Waukesha Memorial Hospital
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Wausau, Wisconsin, Förenta staterna, 54401
- Aspirus Wausau Hospital
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Wauwatosa, Wisconsin, Förenta staterna, 53226
- Aurora Health Care Metro, Inc.
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Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- UW Cancer Center-Riverview
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
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: 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)
Andra namn:
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response Rate
Tidsram: Up to 60 months
|
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
|
|
Progression Free Survival
Tidsram: Up to 60 months
|
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).
|
Up to 60 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety of This Regimen
Tidsram: Up to 36 months
|
Safety of the regimen will be measured by frequency and severity of adverse events.
|
Up to 36 months
|
|
Complete Response Rate
Tidsram: Up to 60 months
|
The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
|
Up to 60 months
|
|
Tolerability of the Regimen
Tidsram: Up to 36 months
|
Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
|
Up to 36 months
|
|
Duration of Response
Tidsram: Up to 60 months
|
Duration of Response is how long a response to therapy is held before a subject has progressive disease.
|
Up to 60 months
|
|
Overall Survival
Tidsram: Up to 60 months
|
Length of time from enrollment until death.
|
Up to 60 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Brad S Kahl, MD, Universtity of Wisconsin- Madison
- Studiestol: Timothy S Fenske, MD, Medical College of Wisconsin
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2011
Primärt slutförande (Faktisk)
1 oktober 2013
Avslutad studie (Faktisk)
1 juni 2014
Studieregistreringsdatum
Först inskickad
20 januari 2011
Först inskickad som uppfyllde QC-kriterierna
21 januari 2011
Första postat (Uppskatta)
24 januari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 december 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 december 2019
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Lymfom, icke-Hodgkin
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Bortezomib
- Sirolimus
Andra studie-ID-nummer
- HO10407
- A534260 (Annan identifierare: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Annan identifierare: UW Madison)
- H-2010-0393 (Annan identifierare: IRB)
- NCI-2011-00647 (Registeridentifierare: NCI Trial ID)
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 .