Imexon for Relapsed Follicular and Aggressive Lymphomas (ULYM11011)

December 4, 2015 updated by: Paul Barr, University of Rochester

A Phase II Study of Amplimexon® (Imexon for Injection) for the Treatment of Previously Treated Follicular and Aggressive Lymphoma in Adults

The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A phase II exploratory trial of imexon in lymphoma is justified by: (1) the observation of clinical activity (partial response to the drug observed in phase I testing in a subject with refractory indolent lymphoma); (2) the finding that imexon prevents the development of human immunoblastic lymphoma in SCID mice; (3) the finding that lymphoma cell lines are killed by readily achievable doses; and (4) translational studies implicating the importance of the redox state of the cancer cell.

The dose and schedule chosen (1000 mg/m2 daily X 5 days every 3 weeks) is based on tolerability and subject acceptance in prior AmpliMed phase I studies.

The planned correlative studies should help to identify potential biomarkers for response to imexon and provide further insight into potential mechanisms of imexon action hypothesized from results of prior laboratory studies.

Study Type

Interventional

Enrollment (Actual)

22

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center, University of Arizona
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical 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:

  1. Diagnosis:

    Group 1: Histologically confirmed indolent NHL, including follicular (any grade), small lymphocytic lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphomaGroup 2: histologically confirmed diffuse large B-cell, mantle cell, Burkitt, Burkitt-like, and diffuse large B-cell transformed from indolent non-Hodgkin's lymphoma.

  2. Prior treatment:

    Group 1: (indolent histologies): Patients must have demonstrated relapsed or refractory disease to 1 prior treatment regimen. The maximum number of prior regimens used for treatment is not specified.

    Group 2: (aggressive histologies): Patients must have demonstrated relapsed or refractory disease to at least 1 prior treatment regimen. In the case of de novo diffuse large B-cell lymphoma, prior treatment must include R-CHOP or R-CHOP-like therapy, as well as second line autologous stem cell transplantation unless the patient is not eligible. The maximum number of prior regimens is not specified.

  3. At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response Criteria for Malignant Lymphoma.
  4. ECOG Performance Status 0-2.
  5. No clinical or laboratory evidence of central nervous system disease.
  6. Adult (age 18 years or older).
  7. Projected life expectancy >4 months.
  8. If female, neither pregnant (negative pregnancy test required at screening) nor lactating.
  9. If of child-bearing potential, must be able to use and agree to use medically acceptable contraception for the duration of the study. For female subjects who are neither post-menopausal nor surgically sterilized, this includes oral or injectable hormonal methods, barrier methods such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Male subjects must also agree to use an acceptable method for contraception for the duration of the study.
  10. No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery.
  11. No evidence of other concurrent active malignancy.
  12. At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy.
  13. Prior radiotherapy to less than an estimated 25% of the bone marrow. In addition, the target lesion(s) must not have been previously irradiated.

  14. Clinical laboratory values within the following limits:

    1. Hgb >/=10.0 g/dL
    2. Absolute neutrophil count ANC >/=1,500/mm3
    3. Platelets >/=75,000/mm3
    4. Serum creatinine </=2.0 times upper limit of normal
    5. Serum bilirubin </=2.0 times upper limit of normal
    6. Serum AST and ALT </=3 times upper limit of normal
  15. G6PD level >/= lower limit of normal
  16. Able and willing to render informed consent and to follow protocol requirements.

Exclusion Criteria:

  1. Diagnosis of lymphoma based on fine needle aspirate.
  2. Curative therapy is indicated or possible.
  3. Absence of a measurable target lesion, or the only target lesion was previously irradiated.
  4. Symptoms, exam findings, or laboratory findings to suggest central nervous system disease involvement.
  5. Age < 18 years
  6. Projected life expectancy <4 months.
  7. Pregnant or lactating.
  8. Unable or unwilling to use medically acceptable contraception, if of childbearing potential.
  9. Evidence of major infection or other serious uncontrolled concomitant illness. Not fully recovered from prior major surgery.
  10. Evidence of other active malignancy.
  11. Prior radiotherapy, antibody therapy, or cancer chemotherapy within 4 weeks before start of treatment (2 weeks for corticosteroids). Prior radiotherapy to >25% of the bone marrow.
  12. Clinical laboratory values outside of permitted ranges.
  13. Respiratory insufficiency requiring oxygen therapy; angina at rest, or myocardial infarction in previous 3 months; history of life threatening ventricular arrhythmia; uncompensated CHF or NYHA Grade 3 or 4 cardiac disease.
  14. Unable or unwilling to give informed consent and to follow protocol requirements.
  15. Failure to meet any of the eligibility criteria.

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: Imexon
Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Drug: Imexon
Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Other Names:
  • Amplimexon (imexon for injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas
Time Frame: One year
CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas
Time Frame: up to 25 months
Measured from start of treatment until disease progression or death from any cause.
up to 25 months

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

University of Arizona

Investigators

  • Principal Investigator: Paul M Barr, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36191

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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