A Multicenter Open-Label Non-Randomized Phase II Study of 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.