Non-Hodgkin's Lymphoma
Conditions
Brief summary
The purpose of this study is to evaluate the safety of an experimental drug called Elsamitrucin in people with non-Hodgkin's lymphoma and to see if it can shrink their tumors. Elsamitrucin has not been approved by the Food and Drug Administration (FDA). However, the FDA is permitting the use of this drug for this study.
Interventions
DRUGElsamitrusin
Sponsors
Spectrum Pharmaceuticals, Inc
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed