Bortezomib in Treating Patients With Lymphoproliferative Disorders

November 2, 2015 updated by: National Cancer Institute (NCI)

Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders

Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the frequency and duration of complete and partial response rates in patients with grade I, II, or III follicular lymphoma or mantle cell lymphoma treated with bortezomib.

SECONDARY OBJECTIVES:

I. Determine the response of minimal residual disease by polymerase chain reaction (PCR) detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated with this regimen.

II. Determine the time to progression and overall survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle cell lymphoma).

Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.

Patients are followed every 3 months for 1 year and then every 4 months for 2 years.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes:

  • * Relapsed or refractory grade I, II, or III follicular center cell lymphoma

    • Relapsed or refractory mantle cell lymphoma

  • Measurable disease for non-Hodgkin's lymphoma (NHL) only

    • At least 1 unidimensionally measurable lesion
    • At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan
    • Lymph nodes no greater than 1 cm in short axis considered normal
  • Absolute lymphocytosis greater than 5,000/mm^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL
  • No known brain metastases
  • Performance status - Karnofsky 70-100%
  • At least 3 months
  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,500/mm^3 (500/mm^3 if lymphomatous involvement of bone marrow)
  • Platelet count greater than 50,000/mm^3
  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)
  • Creatinine less than 1.5 times ULN
  • No symptomatic congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No cerebrovascular accident or transient ischemic attack within the past 6 months
  • No history of orthostatic hypotension
  • No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram
  • No uncontrolled hypertension requiring antihypertensive medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Febrile episodes up to 38.5°C allowed if no evidence of active infection
  • No other uncontrolled concurrent illness
  • No known or active HIV infection
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study entry
  • At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)
  • No more than 3 prior regimens of conventional cytotoxic chemotherapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • At least 1 week since prior steroid therapy
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior major surgery
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive an infusion of bortezomib (dose of 1.8 mg/m2) over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
Drug: bortezomib
Given IV
Other Names:
  • MLN341
  • LDP 341
  • VELCADE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Up to 3 years
The response probability will be estimated. The 95% confidence interval will be provided.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Gerecitano, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01406 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U01CA062502 (U.S. NIH Grant/Contract)
  • P30CA008748 (U.S. NIH Grant/Contract)
  • N01CM62206 (U.S. NIH Grant/Contract)
  • 2795 (Other Identifier: CTEP)
  • UNMC-03903
  • MSKCC-01049
  • NCI-2795
  • CDR0000068860
  • CWRU-MSKCC-1Y02
  • 01-049 (Other Identifier: Memorial Sloan-Kettering Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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