TheranosticTrials.org

Clinical Trial · NCT00062114

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

Overview

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.

Sponsor

Alliance for Clinical Trials in Oncology

Phase

Phase 2

Contacts

Thomas C. Shea, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00062114

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Patients with peritoneal invasion and/or ascites with positive cytology for lymphoma OR pleural invasion and/or effusion with positive cytology for lymphoma are eligible only if their effusion or ascites can be tapped dry
  • 18 and overPerformance status
  • Presence of B symptoms
  • Greater than 2 cm OR 1.5 cm if 0.5 cm slices are used during spiral CT scan
  • Must have received and either relapsed or failed to respond to prior therapy for initial low grade or follicular NHL
  • Leptomeningeal disease
  • At least 3 weeks since prior anticancer surgery and recovered
  • At least 3 weeks since prior anticancer immunotherapy (6 weeks for rituximab) and recovered
  • Nonmeasurable disease includes any of the following:
  • Platelet count at least 150,000/mm\^3Hepatic
  • At least 3 weeks since other prior anticancer therapy and recovered
  • Must have less than 25% bone marrow involvement with lymphoma
  • HIV negative
  • More than 4 weeks since prior major surgery (other than diagnostic surgery)Other
  • 0-2Life expectancy
  • Absolute neutrophil count at least 1,500/mm\^3
  • Lymphangitis cutis/pulmonis
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Presence of masses that are causing ongoing clinical symptomatology
  • Fertile patients must use effective contraception during and for 1 year after study treatment
  • Hypocellular bone marrow (less than 15% cellularity)
  • Requiring treatment as determined by any of the following characteristics:
  • Initial large cell follicular lymphoma must progress to a diffuse large cell lymphoma
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • At least 3 weeks since prior anticancer radiotherapy and recovered
  • Inflammatory breast disease
  • Pleural or pericardial effusion
  • Bone lesions
  • Transformation defined as:
  • An increase in overall tumor size
  • History of failed stem cell collection
  • Ascites
  • Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
  • De novo transformed NHL ineligible
  • Negative pregnancy test
  • Creatinine no greater than 2.0 mg/dLOther
  • Lymphocyte count no greater than 5,000/mm\^3
  • Must have bidimensionally measurable disease defined as:
  • At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosourea or mitomycin) and recoveredEndocrine therapy
  • Progression to a more aggressive diffuse lymphoma, excluding conversion to a more aggressive grade of follicular lymphoma (e.g., WHO/REAL follicular center, large, grade III NHL)
  • Cystic lesions
  • Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
  • Lesions that are situated in a previously irradiated area
  • Platelet count less than 150,000/mm\^3
  • Bilirubin no greater than 2.0 mg/dLRenal

Exclusion

  • No human anti-mouse antibody (HAMA) reactivity (patients with prior exposure to murine antibodies)Biologic therapy
  • No prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescueChemotherapy
  • No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan
  • No significant remaining malignant effusion or ascites at the time of study drug administration
  • No concurrent systemic corticosteroids with either of the following dose schedules:
  • No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional)Surgery
  • No greater than 50 mg of prednisone as a single dose (or equivalent)
  • Not pregnant or nursing
  • Not specifiedHematopoietic
  • No greater than 50 mg of prednisone per dose (or equivalent) for more than 6 dosesRadiotherapy
  • No expected impairment in bone marrrow reserve meeting any of the following criteria: