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

This study is currently recruiting participants.
Verified March 2014 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Pfizer
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01281917
First received: January 20, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Non-Hodgkins Lymphoma
Drug: Velcade
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Overall Response Rate and Progression Free Survival [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    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.

  • Progression Free Survival [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Safety of this regimen [ Time Frame: 36 months from start ] [ Designated as safety issue: Yes ]
    Safety of the regimen will be measured by frequency and severity of adverse events.

  • Complete Response Rate [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.

  • Tolerability of the regimen [ Time Frame: 36 months from start ] [ Designated as safety issue: No ]
    Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.

  • Duration of Response [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    Duration of Response is how long a response to therapy is held before a subject has progressive disease.

  • Overall Survival [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    Length of time from enrollment until death.


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Other Name: bortezomib, PS-341
Drug: Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281917

Contacts
Contact: Jordan R Kostlevy, BA 608-262-7202 jk2@medicine.wisc.edu

Locations
United States, South Dakota
Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Amy Boylan, RN    605-719-2325    aboylan1@regionalhealth.com   
United States, Wisconsin
Bellin Memorial Hospital, Inc Recruiting
Green Bay, Wisconsin, United States, 54313
Contact: Kathleen Geisen, CCRP    920-435-8326    kageis@bellin.org   
Aurora Baycare Medical Center-GreenBay Recruiting
Green Bay, Wisconsin, United States, 54143
Contact: Lori Bode    414-649-5821    lori.bode@aurora.org   
St Vincent Regional Cancer Center CCOP Not yet recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Jolene Cheslock    920-433-8272    jolene.cheslock@stvgb.org   
Gunderson Lutheran Health System Recruiting
LaCrosse, Wisconsin, United States, 54601
Contact: Chris Meyer, CCRP    608-775-2837      
UW Health Oncology- 1 S Park Recruiting
Madison, Wisconsin, United States, 53715
Contact: Sandra Black    608-287-3032    sandra.black@uwmf.wisc.edu   
University Of Wisconsin Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Brad S Kahl, MD    608-263-1836    bsk@medicine.wisc.edu   
Contact: Jordan R Kostlevy, BA    608-262-7202    jk2@medicine.wisc.edu   
Aurora BayCare Medical Center Recruiting
Marinette, Wisconsin, United States
Contact: Mary Ellen Walters    920-288-4123    maryellen.walters@aurora.org   
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Jane M Carl    715-389-4878    carl.jane@mcfr.mfldclin.edu   
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Debra Pastorek    414-805-6837    dpastore@mcw.edu   
Principal Investigator: Timothy S Fenske, MD         
Columbia St Mary's, Inc Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Debby Baumgarten, RN    414-291-1517    dbaumga1@columbia-stmarys.org   
Aurora Sheboygan Memorial Medical Center Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Mary Theodoroff, RN, BSN    920-457-6800 ext 2654    mary.theodoroff@aurora.org   
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Nancy Briggs, RN, MSN    262-434-8866    nancy.briggs@aurora.org   
Aurora Medical Center in Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Mary Jo Lindemann    920-793-6106    mary.jo.lindemann@aurora.org   
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Sherry Bucholtz    262-928-7779    sherry.bucholtz@phci.org   
Aspirus Wausau Hospital Not yet recruiting
Wausau, Wisconsin, United States, 54401
Contact: Beth Knetter, RN    715-847-2353    beth.knetter@aspirus.org   
Aurora Health Care Metro, Inc. Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Jan DeBartolo    414-778-4345      
UW Cancer Center-Riverview Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Diane Maciejewski, RN    715-422-7718    macdia@rhahealthcare.org   
Sponsors and Collaborators
University of Wisconsin, Madison
Millennium Pharmaceuticals, Inc.
Pfizer
Investigators
Principal Investigator: Brad S Kahl, MD Universtity of Wisconsin- Madison
Study Chair: Timothy S Fenske, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01281917     History of Changes
Other Study ID Numbers: H-2010-0393, HO10407
Study First Received: January 20, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
velcade
temsirolimus
non-hodgkins lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Bortezomib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014