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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT00184080

Collaborator

Spectrum Pharmaceuticals, Inc (Industry)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Elsamitrusin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90032

Sponsors and Collaborators

University of Southern California
Spectrum Pharmaceuticals, Inc

Investigators

Principal Investigator: Ann Mohrbacher, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00184080

Other Study ID Numbers:

13NHL-04-1

First Posted:

Sep 16, 2005

Last Update Posted:

May 21, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of May 21, 2014