Safety Study of NHL With 90Y-hLL2 IgG

This is an interventional treatment trial for NHL focused on measuring NHL, B-cell NHL, Non-Hodgkins lymphoma Read More

Inclusion Criteria:

• All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies.
• Patients must be > 18 years of age
• Measurable disease by CT, with at least one lesion > 1.5 cm in one or both dimensions
• less than 25% bone marrow involvement as determined by bone marrow biopsy
• Patient must have greater than 15% cellularity of the bone marrow.
• Patients must be at least 4 weeks beyond any major surgery.
• Patients must be at least 4 weeks beyond any radiation therapy to the index lesion and must have recovered from radiation induced toxicity.
• Patients must be at least 4 weeks beyond prior chemotherapy and/or immunotherapy, or 2-weeks after corticosteroids, and their blood counts must be within the eligibility criteria. Corticosteroids may, however, be given concomitantly if used to treat adrenal insufficiency
• Patients must have a performance status of 70 or greater on the Karnofsky scale equivalent to ECOG 0-1 (See Appendix A) and a minimal life expectancy of 6 months.
• Patients must be able to give cognizant informed consent.

Exclusion Criteria:

• Patients with a significant concurrent medical complication including severe anorexia, nausea or vomiting that in the judgement of the Investigator could affect the patient's ability to tolerate or complete this study.
• Patients with metastasis to the brain.
• Patients with extensive irradiation to more than 25% of their red marrow will be excluded, except those who had total body irradiation in the context of bone marrow or stem cell transplantation regimen with subsequent engraftment of a functional marrow (i.e., resulting in normal peripheral blood counts). Subjects who have received external radiation to specific organs or areas at the maximum tolerated level are also excluded.
• Women who test positive for pregnancy.
• Patients with splenomegaly.
• Patients with > 4 treatment regimens prior to this protocol, including chemotherapy, radiotherapy and/or other immunotherapy.
• Patients with prior radioimmunotherapy treatments (unless for retreatment under this protocol).
• Patients receiving rituximab within 3 months, unless progressing after treatment.
• Patients with <50% LVEF by required MUGA or 2-D ECHO.
• Patients with <60% of predicted value by required pulmonary function tests.
• Patients who have active Hepatitis B or C or are known HIV positive.
• Patients with another primary malignancy (except basal/squamous cell carcinoma of the skin or carcinoma in-situ of the cervix.
• Patients with other serious medical, surgical, or psychiatric history, unless currently stable and well controlled, without significant increase in treatment medications for at least 30 days preceding study entry.