Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma. | NCT00043459 | Trialant
TerminatedInterventionalPhase 2Updated Jun 24, 2005
Study of T900607-Sodium in Previously Treated Patients With Non-Hodgkin's Lymphoma.
ClinicalTrials.gov ID
NCT00043459
Lead Sponsor
TularikINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 2
Enrollment
35
Last Update Posted
Jun 24, 2005Estimated
Start Date
Jul 2002
Completion Date
Mar 2003
Brief Summary
The purpose of the study is to determine whether T900607-sodium is effective and safe in treating non-Hodgkin's lymphoma.
Non-Hodgkin's Lymphoma
intravenous T900607-sodium
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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