Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma

Exclusion Criteria

• •1. Received antineoplastic, experimental, and/or radiation therapy within the 3 weeks prior to Study Day 1
• •2. Has not recovered to ≤ Grade 1 from all toxicities related to prior treatments
• •3. Prior radioimmunotherapy for NHL
• •4. Autologous stem cell transplant within the 3 months prior to Study Day 1, and/or any history of allogeneic stem cell transplant with continued allogeneic hematopoiesis
• •5. Platelet transfusion within the 7 days prior to Study Day 1
• •6. History of porphyria
• •7. Grade 2 or higher peripheral neuropathy within the 14 days prior to Study Day 1
• •8. History of or active central nervous system disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, brain metastases)
• •9. Ongoing, active infection that requires anti infective therapy
• •10. Clinically significant cardiovascular disease (e.g., unstable angina pectoris, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, myocardial infarction, New York Heart Association \[NYHA\] Class 2 or higher congestive heart failure, Grade 2 or higher peripheral vascular disease) within the 12 months prior to Study Day 1
• •11. History of another clinically significant medical condition, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or place the patient at high risk of treatment complications and/or of noncompliance with the study procedures
• •12. Major surgical procedure and/or significant traumatic injury (that which could interfere with the patient's ability to receive protocol therapy as determined by the principal investigator) within the 28 days prior to Study Day 1, and/or patient is anticipated to require a major surgical procedure during the study period
• •13. Diagnosed with and/or treated for a malignancy other than NHL within the 2 years prior to Study Day 1, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, and/or low-risk prostate cancer after curative therapy from which the patient has been disease-free for at least 1 year
• •14. Evidence of a bleeding diathesis and/or a coagulopathy
• •15. Known HIV infection
• •16. Known hypersensitivity to drugs with porfyrin-like structures, like Visudyne™.
• •17. Positive Hepatitis B or C infection: Patient must be tested for hepatitis B surface antigen.
• •18. Pregnant or lactating woman
• •19. Full dose oral or parenteral anticoagulants within the 10 days prior to Study Day 1, and/or anticipated full dose oral or parenteral anticoagulant therapy during the study period(except as required to maintain patency of pre-existing, permanent, indwelling intravenous catheters) or thrombolytic agents
• •20. Participated in another clinical study within the 4 weeks prior to Study Day 1