A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.
Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : ONTAK (denileukin diftitox, DAB389 IL-2)
Phase: Phase 2
Ages Eligible For Study:
- Pathological diagnosis of peripheral T-cell lymphoma of one of the following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma. - Treatment na´ve except for prior radiation or a single cycle of CHOP. - Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography. - Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. - At least 18 years of age. - Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) > or equal to 1000/microL, platelets > or equal to 50,000/microL (25,000/MicroL if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin > or equal to 8 g/dL. - Adequate liver function, indicated by bilirubin < or equal to 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) < or equal to 2 times the ULN or aspartate transaminase (AST) < or equal to 2.0 times the ULN, and albumin > or equal to 3.0 g/dL. - Adequate renal function, indicated by serum creatinine < or equal to 2.5 mg/dL. - Women of childbearing potential and sexually active males agree to use an accepted and effective method of contraception. - Able to give informed consent.