Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
NCT ID: NCT01281917
Last Updated: 2019-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2011-02-28
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Interventions
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Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Pfizer
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Brad S Kahl, MD
Role: PRINCIPAL_INVESTIGATOR
Universtity of Wisconsin- Madison
Timothy S Fenske, MD
Role: STUDY_CHAIR
Medical College of Wisconsin
Locations
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Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
Rapid City, South Dakota, United States
Aurora Baycare Medical Center-GreenBay
Green Bay, Wisconsin, United States
St Vincent Regional Cancer Center CCOP
Green Bay, Wisconsin, United States
Bellin Memorial Hospital, Inc
Green Bay, Wisconsin, United States
Gunderson Lutheran Health System
La Crosse, Wisconsin, United States
UW Health Oncology- 1 S Park
Madison, Wisconsin, United States
University Of Wisconsin Cancer Center
Madison, Wisconsin, United States
Aurora BayCare Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Columbia St Mary's, Inc
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Sheboygan Memorial Medical Center
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Aurora Medical Center in Two Rivers
Two Rivers, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Aurora Health Care Metro, Inc.
Wauwatosa, Wisconsin, United States
UW Cancer Center-Riverview
Wisconsin Rapids, Wisconsin, United States
Countries
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Other Identifiers
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H-2010-0393
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-00647
Identifier Type: REGISTRY
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
HO10407
Identifier Type: -
Identifier Source: org_study_id