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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Multicenter Open-Label Non-Randomized Phase II Study of Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184080
• Other study ID #: 13NHL-04-1
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 20, 2014
• Start date: May 2004
• Est. completion date: April 2006

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Elsamitrusin

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States,