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

11 de diciembre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Otros nombres:
  • bortezomib, PS-341
Droga: Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Otros nombres:
  • Torisel

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Response Rate
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety of This Regimen
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 60 months
Length of time from enrollment until death.
Up to 60 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Wisconsin, Madison

Colaboradores

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

Investigadores

  • Investigador principal: Brad S Kahl, MD, Universtity of Wisconsin- Madison
  • Silla de estudio: Timothy S Fenske, MD, Medical College of Wisconsin

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2011

Finalización primaria (Actual)

1 de octubre de 2013

Finalización del estudio (Actual)

1 de junio de 2014

Fechas de registro del estudio

Enviado por primera vez

20 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

21 de enero de 2011

Publicado por primera vez (Estimar)

24 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de diciembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

11 de diciembre de 2019

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HO10407
  • A534260 (Otro identificador: UW Madison)
  • SMPH\MEDICINE\HEM-ONC (Otro identificador: UW Madison)
  • H-2010-0393 (Otro identificador: IRB)
  • NCI-2011-00647 (Identificador de registro: NCI Trial ID)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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