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Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
This study has been terminated.
Sponsored by: Tularik
Information provided by: Tularik
ClinicalTrials.gov Identifier: NCT00043459
  Purpose

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


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: intravenous T900607-sodium
Phase II

MedlinePlus related topics: Dietary Sodium Lymphoma
Drug Information available for: T 900607
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Tularik:

Estimated Enrollment: 35
Study Start Date: July 2002
Estimated Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043459

Locations
United States, California
Scripps Health Center
La Jolla, California, United States, 92037
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Illinois
Rush Medical Center
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Tularik
Investigators
Study Chair: Kerrie Boyd Tularik
  More Information

Study ID Numbers: T-607-007
Study First Received: August 8, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00043459  
Health Authority: United States: Food and Drug Administration

Keywords provided by Tularik:
NHL

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009