search
Back to results

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

Primary Purpose

Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elsamitrucin
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alta Bates Cancer Center
  • Providence Saint Joseph Medical Center
  • USC Norris Cancer Center
  • Tower Hematology Oncology Medical Group
  • North Valley Hematology Oncology Medical Group
  • Cancer and Blood Institute Medical Group
  • North Shores University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 24, 2004
Last Updated
January 8, 2008
Sponsor
Spectrum Pharmaceuticals, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00090090
Brief Title
Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Elsamitrucin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Alta Bates Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Providence Saint Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
North Valley Hematology Oncology Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
Cancer and Blood Institute Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
North Shores University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8913843
Citation
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. doi: 10.1007/BF00210793.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs