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

This study has been completed.

Sponsored by:	Spectrum Pharmaceuticals, Inc
Information provided by:	Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00090090

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 II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Elsamicin A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090090

Locations

United States, California
USC Norris Cancer Center
Los Angeles, California, United States, 90033
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
North Valley Hematology Oncology Medical Group
Mission Hills, California, United States, 91343
Alta Bates Cancer Center
Berkeley, California, United States, 94704
Tower Hematology Oncology Medical Group
Los Angeles, California, United States, 90048
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:

Allen SL, Schacter LP, Lichtman SM, Bukowski R, Fusco D, Hensley M, O'Dwyer P, Mittelman A, Rosenbloom B, Huybensz S. Phase II study of elsamitrucin (BMY-28090) for the treatment of patients with refractory/relapsed non-Hodgkin's lymphoma. Invest New Drugs. 1996;14(2):213-7.

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

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Elsamicin A
Mantle cell lymphoma

Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009