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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00054834
Other study ID # IM-T-hLL2-14
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date March 2003

Study information

Verified date January 2008
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Disease Characteristics: - Patients with a documented histologic or cytologic diagnosis of B-cell NHL. - Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority. - Patients with at least one measurable tumor site > 1.5 cm in at least one dimension. Prior/Concurrent Therapy: - Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. - Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA). - Radiotherapy: No prior radiation therapy to >25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible. Patient Characteristics/Inclusion Criteria: - Age Range: Male or Female at least 18 years of age - Performance Status: Patients with a Karnofsky performance status > 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks. - Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L; - Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or <5 x ULN w/liver metastases - Renal: Creatinine < 2.0 mg/dL - Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO. - Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests. - Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
hLL2 (epratuzumab)


Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

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