Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma

Inclusion Criteria

• •1. Patients must be at least 18 years of age.
• •2. Patients must have biopsy confirmed low-grade B-cell lymphoma (follicular, marginal zone, or small cell/chronic lymphocytic leukemia) or mycosis fungoides. B-cell lymphoma patients must have failed at least one prior therapy (chemotherapy or immunotherapy) or mycosis fungoides patients failed at least 1 topical or systemic treatment.
• •3. Patients must have at least one accessible tumor site that can be injected with poly-ICLC.
• •4. Patients must have measurable disease other than the injection site.
• •5. Patients must have a Karnofsky performance status of at least 70%.
• •6. Patients must have adequate hematologic, renal and liver function (i.e., absolute neutrophil count at least 1500/mm3, Platelets at least 100,000/mm3, creatinine no more than 1.7 mg/dl, total bilirubin no more than 1.5 mg/dl, transaminases no more than 4 times above the upper limits of the institutional normal).
• •7. Patients must be able to provide written informed consent.
• •8. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. While animal testing has been negative, the anti-proliferative activity of this experimental drug may theoretically be harmful to the developing fetus or nursing infant.
• •9. Required washout period for prior therapy:
• •* Topical therapy: 2 weeks.
• •* Chemotherapy: 4 weeks
• •* Radiotherapy: (including phototherapy): 4 weeks 13 of 26
• •* Biological therapies: 4 weeks
• •* Other investigational therapy: 4 weeks
• •* Rituximab: 12 weeks