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

This study has been completed.
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00184080
First received: September 13, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Elsamitrusin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Enrollment: 7
Study Start Date: May 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184080

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: Luigi Lenaz, Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00184080     History of Changes
Other Study ID Numbers: 13NHL-04-1
Study First Received: September 13, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014