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

Stopped early · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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

Key facts

Study ID

NCT00043459

Run by

Tularik

People needed

35

Starts

2002-07-01

Expected to finish

2003-03-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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

Where it is running

• Scripps Health Center — La Jolla, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Rush Medical Center — Chicago, Illinois, United States
• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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