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

This study has been completed.
Sponsor:
Information provided by:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00090090
First received: August 24, 2004
Last updated: January 8, 2008
Last verified: January 2008
  Purpose

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).


Condition Intervention Phase
Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Drug: Elsamitrucin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Non-Randomized Phase II Study of Elsamitrucin (SPI 28090) In Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Estimated Enrollment: 114
Study Start Date: April 2004
Study Completion Date: October 2006
  Eligibility

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

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
  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: NCT00090090

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

Publications:
ClinicalTrials.gov Identifier: NCT00090090     History of Changes
Other Study ID Numbers: ELSA 2004-001
Study First Received: August 24, 2004
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Elsamicin A
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014