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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overOtherH-2010-0393
HO10407, NCT01281917

Trial Description

Summary

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Millennium Pharmaceuticals, Incorporated

Pfizer Incorporated

Brad S. KahlPrincipal Investigator

Timothy S Fenske, MDStudy Chair

Jordan R Kostlevy, BAPh: 608-262-7202
  Email: jk2@medicine.wisc.edu

Trial Sites

U.S.A.
South Dakota
  Rapid City
 Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
 Amy Boylan, RN Ph: 605-719-2325
  Email: aboylan1@regionalhealth.com
Wisconsin
  Green Bay
 Aurora Baycare Medical Center-GreenBay
 Lori Bode Ph: 414-649-5821
  Email: lori.bode@aurora.org
 Bellin Memorial Hospital, Inc
 Kathleen Geisen, CCRP Ph: 920-435-8326
  Email: kageis@bellin.org
  LaCrosse
 Gunderson Lutheran Health System
 Chris Meyer, CCRP Ph: 608-775-2837
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Sandra Black Ph: 608-287-3032
  Email: sandra.black@uwmf.wisc.edu
 Brad S Kahl, MD Ph: 608-263-1836
  Email: bsk@medicine.wisc.edu
 Jordan R Kostlevy, BA Ph: 608-262-7202
  Email: jk2@medicine.wisc.edu
  Marinette
 Aurora BayCare Medical Center
 Mary Ellen Walters Ph: 920-288-4123
  Email: maryellen.walters@aurora.org
  Marshfield
 Marshfield Clinic - Marshfield Center
 Jane M Carl Ph: 715-389-4878
  Email: carl.jane@mcfr.mfldclin.edu
  Milwaukee
 Columbia-Saint Mary's Cancer Care Center
 Debby Baumgarten, RN Ph: 414-291-1517
  Email: dbaumga1@columbia-stmarys.org
 Medical College of Wisconsin Cancer Center
 Debra Pastorek Ph: 414-805-6837
  Email: dpastore@mcw.edu
 Timothy S Fenske, MDPrincipal Investigator
  Sheboygan
 Aurora Sheboygan Memorial Medical Center
 Mary Theodoroff, RN, BSN Ph: 920-457-6800 Ext.2654
  Email: mary.theodoroff@aurora.org
  Summit
 Aurora Medical Center in Summit
 Nancy Briggs, RN, MSN Ph: 262-434-8866
  Email: nancy.briggs@aurora.org
  Two Rivers
 Aurora Medical Center in Two Rivers
 Mary Jo Lindemann Ph: 920-793-6106
  Email: mary.jo.lindemann@aurora.org
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Sherry Bucholtz Ph: 262-928-7779
  Email: sherry.bucholtz@phci.org
  Wauwatosa
 Aurora Health Care Metro, Inc.
 Jan DeBartolo Ph: 414-778-4345
  Wisconsin Rapids
 UW Cancer Center-Riverview
 Diane Maciejewski, RN Ph: 715-422-7718
  Email: macdia@rhahealthcare.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01281917
ClinicalTrials.gov processed this data on March 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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