Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's Lymphoma

January 8, 2008 updated by: Spectrum Pharmaceuticals, Inc

A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

To determine the safety and efficacy of elsamitrucin in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). To determine if elsamitrucin is efficacious in a particular pathologic NHL subtype(s).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Cancer Center
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
      • Mission Hills, California, United States, 91343
        • North Valley Hematology Oncology Medical Group
      • Rancho Mirage, California, United States, 92270
        • Cancer and Blood Institute Medical Group
    • New York
      • Manhasset, New York, United States, 11021
        • North Shores University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma
  • at least one prior cytotoxic chemotherapy regimens
  • measurable disease
  • adequate bone marrow, liver and kidney function
  • ECOG PS 0-2

Exclusion Criteria:

  • prior treatment with elsamitrucin
  • prior chemo, antibody or radiotherapy for NHL within 28 days prior to start to treatment
  • HIV positive or known AIDS syndrome
  • uncontrolled medical disease or psychiatric condition/s

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 24, 2004

First Submitted That Met QC Criteria

August 24, 2004

First Posted (Estimate)

August 25, 2004

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 8, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELSA 2004-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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