search
Back to results

Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
intravenous T900607-sodium
Sponsored by
Tularik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL

Eligibility Criteria

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

Inclusion Criteria Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL) Subjects must have received prior chemotherapy for their NHL At least 18 years of age Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size. Karnofsky performance status of at least 70% Estimated life expectancy of at least 12 weeks Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive Subject must be able to comply with study procedures and follow-up examinations. Signed written informed consent Lab Values (obtained ≤ 7 days prior to study enrollment): ANC at least 1.5x10e9/L, Platelet count at least 100x10e9/L, Hemoglobin at least 8.5 g/dL, Creatinine within 2 times upper limit of normal, AST and ALT within 3 times upper limit of normal, Bilirubin within 1.5 times upper limit of normal, Albumin great than 2.5 g/dL, Exclusion Criteria Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms Patients who have received any investigational agent within 4 weeks of enrollment Patients who are pregnant or breast-feeding History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix History of central nervous system metastases or carcinomatous meningitis Major surgery within 4 weeks of enrollment

Sites / Locations

  • Scripps Health Center
  • University of Colorado Health Sciences Center
  • Northwestern University
  • Rush Medical Center
  • Weill Medical College of Cornell University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2002
Last Updated
June 23, 2005
Sponsor
Tularik
search

1. Study Identification

Unique Protocol Identification Number
NCT00043459
Brief Title
Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Terminated
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tularik

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
NHL

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravenous T900607-sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Histologically or cytologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL) Subjects must have received prior chemotherapy for their NHL At least 18 years of age Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size. Karnofsky performance status of at least 70% Estimated life expectancy of at least 12 weeks Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive Subject must be able to comply with study procedures and follow-up examinations. Signed written informed consent Lab Values (obtained ≤ 7 days prior to study enrollment): ANC at least 1.5x10e9/L, Platelet count at least 100x10e9/L, Hemoglobin at least 8.5 g/dL, Creatinine within 2 times upper limit of normal, AST and ALT within 3 times upper limit of normal, Bilirubin within 1.5 times upper limit of normal, Albumin great than 2.5 g/dL, Exclusion Criteria Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms Patients who have received any investigational agent within 4 weeks of enrollment Patients who are pregnant or breast-feeding History of prior malignancy other than NHL within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix History of central nervous system metastases or carcinomatous meningitis Major surgery within 4 weeks of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Boyd
Organizational Affiliation
Tularik
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Health Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.

We'll reach out to this number within 24 hrs