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Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

11. desember 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54143
        • Aurora Baycare Medical Center-GreenBay
      • Green Bay, Wisconsin, Forente stater, 54301
        • St Vincent Regional Cancer Center CCOP
      • Green Bay, Wisconsin, Forente stater, 54313
        • Bellin Memorial Hospital, Inc
      • La Crosse, Wisconsin, Forente stater, 54601
        • Gunderson Lutheran Health System
      • Madison, Wisconsin, Forente stater, 53715
        • UW Health Oncology- 1 S Park
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Cancer Center
      • Marinette, Wisconsin, Forente stater
        • Aurora BayCare Medical Center
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53211
        • Columbia St Mary's, Inc
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Aurora Sheboygan Memorial Medical Center
      • Summit, Wisconsin, Forente stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forente stater, 54241
        • Aurora Medical Center in Two Rivers
      • Waukesha, Wisconsin, Forente stater, 53188
        • Waukesha Memorial Hospital
      • Wausau, Wisconsin, Forente stater, 54401
        • Aspirus Wausau Hospital
      • Wauwatosa, Wisconsin, Forente stater, 53226
        • Aurora Health Care Metro, Inc.
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • UW Cancer Center-Riverview

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Andre navn:
  • bortezomib, PS-341
Legemiddel: Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Andre navn:
  • Torisel

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: 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.
Up to 60 months
Progression Free Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of This Regimen
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 60 months
Length of time from enrollment until death.
Up to 60 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

National Cancer Institute (NCI)
Pfizer
Millennium Pharmaceuticals, Inc.

Etterforskere

  • Hovedetterforsker: Brad S Kahl, MD, Universtity of Wisconsin- Madison
  • Studiestol: Timothy S Fenske, MD, Medical College of Wisconsin

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2011

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

20. januar 2011

Først innsendt som oppfylte QC-kriteriene

21. januar 2011

Først lagt ut (Anslag)

24. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. desember 2019

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HO10407
  • A534260 (Annen identifikator: UW Madison)
  • SMPH\MEDICINE\HEM-ONC (Annen identifikator: UW Madison)
  • H-2010-0393 (Annen identifikator: IRB)
  • NCI-2011-00647 (Registeridentifikator: NCI Trial ID)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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