A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|