Imexon for Relapsed Follicular and Aggressive Lymphomas

Inclusion Criteria

• 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.

• 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.

• At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response Criteria for Malignant Lymphoma.
• ECOG Performance Status 0-2.
• No clinical or laboratory evidence of central nervous system disease.
• Adult (age 18 years or older).
• Projected life expectancy >4 months.
• If female, neither pregnant (negative pregnancy test required at screening) nor lactating.
• 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.
• No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery.
• No evidence of other concurrent active malignancy.
• At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy.
• Prior radiotherapy to less than an estimated 25% of the bone marrow. In addition, the target lesion(s) must not have been previously irradiated.
• Clinical laboratory values within the following limits:
• Hgb >/=10.0 g/dL
• Absolute neutrophil count ANC >/=1,500/mm3
• Platelets >/=75,000/mm3
• Serum creatinine /= lower limit of normal
• Able and willing to render informed consent and to follow protocol requirements.

Exclusion Criteria

• Diagnosis of lymphoma based on fine needle aspirate.
• Curative therapy is indicated or possible.
• Absence of a measurable target lesion, or the only target lesion was previously irradiated.
• Symptoms, exam findings, or laboratory findings to suggest central nervous system disease involvement.
• Age 25% of the bone marrow.
• Clinical laboratory values outside of permitted ranges.
• 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.
• Unable or unwilling to give informed consent and to follow protocol requirements.
• Failure to meet any of the eligibility criteria.