Imexon for Relapsed Follicular and Aggressive Lymphomas (ULYM11011)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01314014
First received: March 10, 2011
Last updated: May 29, 2014
Last verified: May 2014

March 10, 2011
May 29, 2014
May 2011
March 2013   (final data collection date for primary outcome measure)
Efficacy of Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas [ Time Frame: One year ] [ Designated as safety issue: No ]
To investigate the anti-tumor activity (overall response rate) of imexon monotherapy in the treatment of subjects with indolent lymphoma that has progressed after treatment with standard chemo-immunotherapy, in order to determine whether future clinical trials with imexon is warranted in this population.
  • Efficacy of imexon in the treatment of relapsed/refractory follicular lymphoma [ Time Frame: One year ] [ Designated as safety issue: No ]
    To investigate the anti-tumor activity (overall response rate) of imexon monotherapy in the treatment of subjects with follicular lymphoma that has progressed after treatment with standard chemo-immunotherapy, in order to determine whether future clinical trials with imexon is warranted in this population.
  • Efficacy of imexon in the treatment of relapsed/refractory aggressive lymphomas [ Time Frame: One year ] [ Designated as safety issue: No ]
    To investigate the anti-tumor activity (overall response rate) of imexon in the treatment of subjects with relapsed aggressive histologies of lymphoma who have progressed after salvage auto-transplant or for whom auto-transplant is not appropriate, in order to determine whether future clinical trials with imexon is warranted in this population.
Complete list of historical versions of study NCT01314014 on ClinicalTrials.gov Archive Site
Progression Free Survival in Relapsed/Refractory Indolent and Aggressive Lymphomas [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]
To document progression free survival (measured from start of treatment until disease progression or death from any cause) in relapsed/refractory indolent and aggressive lymphomas.
  • Duration of response in relapsed/refractory follicular and aggressive lymphomas [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]
    To document duration of response (measured from time when best response is determined until disease progression is documented or death from any cause, which ever event comes first) in relapsed/refractory follicular and aggressive lymphomas.
  • Time to disease progression in relapsed/refractory follicular and aggressive lymphomas [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]
    To document time to disease progression (measured from start of treatment until disease progression or death from any cause) in relapsed/refractory follicular and aggressive lymphomas.
Not Provided
Not Provided
 
Imexon for Relapsed Follicular and Aggressive Lymphomas
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Follicular Lymphoma
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Mantle Cell Lymphoma
  • Burkitt's Lymphoma
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 Name: Amplimexon (imexon for injection)
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.
Intervention: Drug: Imexon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
May 2015
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314014
36191
Yes
University of Rochester
University of Rochester
University of Arizona
Principal Investigator: Paul M Barr, MD University of Rochester
University of Rochester
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP