Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Inclusion criteria

• Histologically confirmed NHL both B and T-cell that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
• CT or MRI scans confirming measurable tumor size (lymph node must be >1.0 cm in its longest transverse diameter). Measurement by PE is acceptable, in the case of palpable and reproducibly measurable tumors. Patients with CLL/smal lymphocytic lymphoma are eligible without bidimensional measurable disease.
• ECOG Performance Status 0-2
• Age greater or equal to 18 years of old
• AGC greater or equal to 1.0; platelets greater or equal to 75,000;Ggb greater or equal to 9.0. (Lower values may be accepted for cytopenias due to bone marrow involvement by lymphoma, after discussion with sponsor)
• Bilirubin less or equal to 2.0; SGOT and SGPT less of equal to 3 times upper limit of normal
• Creatinine <1.5; BUN <25
• Expected survival >6 months

Exclusion criteria

• Prior therapy with Elsamitrucin
• Any therapy for lymphoma, including chemotherapy, antibody therapy, RT, or any investigational therapy within 28 days prior to study drug administration
• Steroid therapy within the last 4 weeks prior to study drug administration
• Evidence of clinically significant uncontrolled condition/s and/or is considered by investigator to be unable to tolerate the required therapy or procedures
• Known AIDS syndrome or HIV-associated complex (severely depressed immune system)
• Prior or other current malignancy within 5 years, except for adequately treated cone-biopsied in-situ cervical cancer or resected basal cell or squamous cell skin cancer
• Any current medical or psychiatric disease that would prevent informed consent and expected cooperation of the patient for therapy and follow-up
• Pregnant or lactating women.