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Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kerrie Boyd

Investigator Role:

Study Chair

Investigator Affiliation:

Tularik

Authority:

United States: Food and Drug Administration

Study ID:

T-607-007

NCT ID:

NCT00043459

Start Date:

July 2002

Completion Date:

March 2003

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021
Northwestern UniversityChicago, Illinois  60611
University of Colorado Health Sciences CenterDenver, Colorado  80262
Rush Medical CenterChicago, Illinois  60612
Scripps Health CenterLa Jolla, California  92037