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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184080
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 21, 2014
Spectrum Pharmaceuticals, Inc
Information provided by:
University of Southern California

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 Type : Interventional  (Clinical Trial)
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 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184080

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90032
Sponsors and Collaborators
University of Southern California
Spectrum Pharmaceuticals, Inc
Principal Investigator: Ann Mohrbacher, MD University of Southern California

Responsible Party: Luigi Lenaz, Spectrum Pharmaceuticals, Inc Identifier: NCT00184080     History of Changes
Other Study ID Numbers: 13NHL-04-1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Elsamicin A
Antibiotics, Antineoplastic
Antineoplastic Agents