Imexon for Relapsed Follicular and Aggressive Lymphomas

Exclusion Criteria

• •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.
• •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.