Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
5 other identifiers
interventional
40
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2011
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 21, 2017
CompletedDecember 13, 2019
July 1, 2017
2.7 years
January 20, 2011
June 20, 2017
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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).
Up to 60 months
Secondary Outcomes (5)
Safety of This Regimen
Up to 36 months
Complete Response Rate
Up to 60 months
Tolerability of the Regimen
Up to 36 months
Duration of Response
Up to 60 months
Overall Survival
Up to 60 months
Study Arms (1)
Velcade plus Temsirolimus
EXPERIMENTALVelcade 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.
Interventions
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Millennium Pharmaceuticals, Inc.collaborator
- Pfizercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (18)
Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute
Rapid City, South Dakota, 57701, United States
Aurora Baycare Medical Center-GreenBay
Green Bay, Wisconsin, 54143, United States
St Vincent Regional Cancer Center CCOP
Green Bay, Wisconsin, 54301, United States
Bellin Memorial Hospital, Inc
Green Bay, Wisconsin, 54313, United States
Gunderson Lutheran Health System
La Crosse, Wisconsin, 54601, United States
UW Health Oncology- 1 S Park
Madison, Wisconsin, 53715, United States
University Of Wisconsin Cancer Center
Madison, Wisconsin, 53792, United States
Aurora BayCare Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Columbia St Mary's, Inc
Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sheboygan Memorial Medical Center
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Aurora Medical Center in Two Rivers
Two Rivers, Wisconsin, 54241, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Aurora Health Care Metro, Inc.
Wauwatosa, Wisconsin, 53226, United States
UW Cancer Center-Riverview
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lymphoma Disease Oriented Team
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Brad S Kahl, MD
Universtity of Wisconsin- Madison
- STUDY CHAIR
Timothy S Fenske, MD
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 24, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2013
Study Completion
June 1, 2014
Last Updated
December 13, 2019
Results First Posted
August 21, 2017
Record last verified: 2017-07