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Non-Hodgkins LymphomaPhase 2NCT01281917

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

A Phase 2 study testing Velcade and Temsirolimus in people with Non-Hodgkins Lymphoma, run by University of Wisconsin, Madison at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkins Lymphoma
What is being tested?
Velcade and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
18 sitesUnited States
Study dates
Feb 2011to Jun 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 28Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Aurora Baycare Medical Center-GreenBay

    Green Bay, Wisconsin, 54143

  • St Vincent Regional Cancer Center CCOP

    Green Bay, Wisconsin, 54301

  • Bellin Memorial Hospital, Inc

    Green Bay, Wisconsin, 54313

  • Gunderson Lutheran Health System

    La Crosse, Wisconsin, 54601

  • UW Health Oncology- 1 S Park

    Madison, Wisconsin, 53715

  • University Of Wisconsin Cancer Center

    Madison, Wisconsin, 53792

  • Aurora BayCare Medical Center

    Marinette, Wisconsin

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Columbia St Mary's, Inc

    Milwaukee, Wisconsin, 53211

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute

    Rapid City, South Dakota, 57701

  • Aurora Sheboygan Memorial Medical Center

    Sheboygan, Wisconsin, 53081

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Aurora Medical Center in Two Rivers

    Two Rivers, Wisconsin, 54241

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Aurora Health Care Metro, Inc.

    Wauwatosa, Wisconsin, 53226

  • UW Cancer Center-Riverview

    Wisconsin Rapids, Wisconsin, 54494

Other trials in United States

About this study

Official title: 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.

Being tested
Velcade, Temsirolimus
Keywords
velcade, temsirolimus, non-hodgkins lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VelcadeDrug

    Also called bortezomib, PS-341

    Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)

  • TemsirolimusDrug

    Also called Torisel

    Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Study groups in NCT01281917
Study groupRoleWhat they receive
Velcade plus TemsirolimusExperimentalVelcade 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.
Receives: Drug: Velcade; Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 60 months

  2. 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).

    Measured: Up to 60 months

Secondary outcomes (5)

  1. Safety of This Regimen

    Safety of the regimen will be measured by frequency and severity of adverse events.

    Measured: Up to 36 months

  2. Complete Response Rate

    The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.

    Measured: Up to 60 months

  3. Tolerability of the Regimen

    Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.

    Measured: Up to 36 months

  4. Duration of Response

    Duration of Response is how long a response to therapy is held before a subject has progressive disease.

    Measured: Up to 60 months

  5. Overall Survival

    Length of time from enrollment until death.

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01281917
Sponsor's protocol ID
HO10407
Other IDs
H-2010-0393, NCI-2011-00647, A534260, SMPH\MEDICINE\HEM-ONC
Status last verified
Jul 2017
First submitted
20 Jan 2011
Last updated
13 Dec 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Velcade and Temsirolimus in people with Non-Hodgkins Lymphoma, run by University of Wisconsin, Madison at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01281917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.

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