Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:February 2011
End Date:February 2017
Contact:Jordan R Kostlevy, BA
Email:jk2@medicine.wisc.edu
Phone:608-262-7202

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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.


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.
We found this trial at
18
sites
Marinette, Wisconsin 54143
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Marinette, WI
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Green Bay, Wisconsin 54301
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Green Bay, WI
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Green Bay, Wisconsin 54143
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Green Bay, WI
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Green Bay, Wisconsin 54301
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Green Bay, WI
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LaCrosse, Wisconsin 54601
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LaCrosse, WI
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Madison, Wisconsin 53715
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Madison, WI
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Madison, Wisconsin 53792
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Madison, WI
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1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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Marshfield, WI
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Milwaukee, Wisconsin 53211
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Milwaukee, WI
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Rapid City, SD
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Sheboygan, Wisconsin 53081
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Sheboygan, WI
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36500 Aurora Dr
Summit, Wisconsin 53066
262-434-1000
Aurora Medical Center in Summit The Aurora Medical Center in Summit is a state-of-the-art regional...
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Summit, WI
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Two Rivers, Wisconsin 54241
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Two Rivers, WI
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Waukesha, Wisconsin 53188
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Waukesha, WI
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Wausau, Wisconsin 54401
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Wausau, WI
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Wauwatosa, Wisconsin 53226
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Wauwatosa, WI
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Wisconsin Rapids, Wisconsin 54494
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Wisconsin Rapids, WI
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