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

NCT00184080 | Completed Phase 2

• 1 other identifier: 13NHL-04-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Interventions

Elsamitrusin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Spectrum Pharmaceuticals, Inc: collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ann Mohrbacher, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)