Status:
COMPLETED
Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 bee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00184080
Start Date
May 1 2004
End Date
April 1 2006
Last Update
May 21 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90032