Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

Non-Hodgkins Lymphoma Clinical Trial

Official title:

A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00054834
• Other study ID #: IM-T-hLL2-14
• Status: Terminated
• Phase: Phase 1
• Start date: March 2003

Study information

• Verified date: January 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• 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
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

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,