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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
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
Overall Response Rate
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.
Time frame: Up to 60 months
Progression Free Survival
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).
Time frame: Up to 60 months
Safety of This Regimen
Safety of the regimen will be measured by frequency and severity of adverse events.
Time frame: Up to 36 months
Complete Response Rate
The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
Time frame: Up to 60 months
Tolerability of the Regimen
Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
Time frame: Up to 36 months
Duration of Response
Duration of Response is how long a response to therapy is held before a subject has progressive disease.
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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
...and 8 more locations
Time frame: Up to 60 months
Overall Survival
Length of time from enrollment until death.
Time frame: Up to 60 months