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

January 20, 2011
March 18, 2014
February 2011
February 2017   (final data collection date for primary outcome measure)
  • 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).
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) and progression-free survival (PFS).
Complete list of historical versions of study NCT01281917 on ClinicalTrials.gov Archive Site
  • 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.
  • Safety and Tolerability of this regimen [ Time Frame: 36 months from start ] [ Designated as safety issue: Yes ]
    The overall safety and tolerability.
  • Complete Response Rate, Duration of Response, and Overall Survival [ Time Frame: 60 months from start ] [ Designated as safety issue: No ]
    The complete response rate (CR), the duration of response (DOR), and the overall survival (OS).
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkins Lymphoma
  • 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)
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.

Interventions:
  • Drug: Velcade
  • Drug: Temsirolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
February 2017
February 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jordan R Kostlevy, BA 608-262-7202 jk2@medicine.wisc.edu
United States
 
NCT01281917
H-2010-0393, HO10407
No
University of Wisconsin, Madison
University of Wisconsin, Madison
  • Millennium Pharmaceuticals, Inc.
  • Pfizer
Principal Investigator: Brad S Kahl, MD Universtity of Wisconsin- Madison
Study Chair: Timothy S Fenske, MD Medical College of Wisconsin
University of Wisconsin, Madison
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP