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A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkins Lymphoma

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Trial Information

A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate and Progression Free Survival

Outcome Description:

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.

Outcome Time Frame:

60 months from start

Safety Issue:

No

Principal Investigator

Brad S Kahl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtity of Wisconsin- Madison

Authority:

United States: Institutional Review Board

Study ID:

H-2010-0393

NCT ID:

NCT01281917

Start Date:

February 2011

Completion Date:

February 2017

Related Keywords:

  • Non-Hodgkins Lymphoma
  • velcade
  • temsirolimus
  • non-hodgkins lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
University of Wisconsin Cancer CenterMadison, Wisconsin  53792
Aurora Medical Center in SummitSummit, Wisconsin  53066
Bellin Memorial Hospital, IncGreen Bay, Wisconsin  54313
St Vincent Regional Cancer Center CCOPGreen Bay, Wisconsin  54301
UW Health Oncology- 1 S ParkMadison, Wisconsin  53715
Columbia St Mary's, IncMilwaukee, Wisconsin  53211
Aspirus Wausau HospitalWausau, Wisconsin  54401
Rapid City Regional Hospital John T. Vucurevich Cancer Care InstituteRapid City, South Dakota  57701
Aurora Baycare Medical Center-GreenBayGreen Bay, Wisconsin  54143
Gunderson Lutheran Health SystemLaCrosse, Wisconsin  54601
Aurora Sheboygan Memorial Medical CenterSheboygan, Wisconsin  53081
Aurora Medical Center in Two RiversTwo Rivers, Wisconsin  54241
Aurora Health Care Metro, Inc.Wauwatosa, Wisconsin  53226
UW Cancer Center-RiverviewWisconsin Rapids, Wisconsin  54494