Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Biogen Idec
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00005592
First received: May 2, 2000
Last updated: December 30, 2010
Last verified: December 2010
  Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: 90-Y-ibritumomab tiuxetan
Biological: rituximab
Radiation: indium In 111 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols. [ Time Frame: up to 4.25 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To add to the overall efficacy and safety experience in this indication. [ Time Frame: up to 4.25 years ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: November 1999
Study Completion Date: November 2005
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8
For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).
Biological: 90-Y-ibritumomab tiuxetan
IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
Other Name: IDEC-Y2B8
Biological: rituximab
Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
Other Name: Rituximab
Radiation: indium In 111 ibritumomab tiuxetan
IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
Other Name: IDEC-In2B8

Detailed Description:

OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.

OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL) Prior rituximab allowed if no response achieved CD20-positive B-cells in lymph nodes or bone marrow required for small lymphocytic or transformed NHL Less than 25% of bone marrow cellularity in lymphoma cells No impaired bone marrow reserve, as indicated by one or more of the following: Prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue Platelet count less than 100,000/mm3 Hypocellular bone marrow (no more than 15% cellularity) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, or erythroid) History of failed stem cell collection Not eligible for any active ibritumomab tiuxetan investigative protocols No CNS lymphoma, AIDS-related lymphoma, or chronic lymphocytic leukemia No pleural effusion A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: See Disease Characteristics Absolute neutrophil count at least 1,500/mm3 Lymphocyte count no greater than 5,000/mm3 (for small lymphocytic lymphoma) Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No serious nonmalignant disease or infection that would preclude study No antimurine antibody reactivity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 6 weeks since prior rituximab At least 3 weeks since prior immunotherapy and recovered No prior radioimmunotherapy At least 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: See Biologic therapy At least 3 weeks since prior radiotherapy and recovered No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional) Surgery: At least 4 weeks since prior major surgery (other than diagnostic) and recovered Other: At least 3 weeks since prior anticancer therapy and recovered At least 8 weeks since prior phase II drugs and recovered No other concurrent myelosuppressive antineoplastic agents No other concurrent antineoplastic therapy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005592

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
University of Alabama at Birmingham
Biogen Idec
Investigators
Study Chair: Mansoor N. Saleh, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: Mansoor Saleh, M.D./ Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00005592     History of Changes
Other Study ID Numbers: CDR0000067697, UAB-9930, IDEC-106-98
Study First Received: May 2, 2000
Last Updated: December 30, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014