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Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma That Has Relapsed After High-Dose Chemotherapy and Autologous Stem Cell Transplantation
This study has been completed.
Sponsored by: University of Nebraska
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031642
  Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances.

PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.


Condition Intervention Phase
Lymphoma
Drug: rituximab
Drug: yttrium Y 90 ibritumomab tiuxetan
Phase I
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab Immunoglobulins Globulin, Immune Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Safety and efficacy [ Designated as safety issue: Yes ]

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
  • Determine the safety and efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan (IDEC-Y2B8).

  • Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity.

  • Phase II: Once the MTD is determined, 58 additional patients are treated at that dose level as in phase I.

Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation
  • Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks

    • Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis
  • CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following:

    • Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
    • Flow cytometry studies
  • Measurable disease

    • More than 2 cm bidimensionally
  • No active CNS lymphoma
  • No HIV- or AIDS-related lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 150,000/mm^3
  • No transfusion dependency

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver)

Renal:

  • Creatinine less than 2.0 mg/dL
  • No active obstructive hydronephrosis

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study therapy
  • HIV negative
  • No active infection requiring oral or IV antibiotics
  • No human antimurine antibody positivity
  • No other major medical problems

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior growth factors
  • At least 4 weeks since prior biologic therapy
  • No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF])
  • No prior radioimmunotherapy
  • No other concurrent biologic therapy of any kind

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
  • No prior fludarabine
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids except as maintenance for non-cancerous disease

Radiotherapy:

  • See Biologic therapy
  • At least 4 weeks since prior radiotherapy
  • No prior pelvic radiotherapy
  • No prior radiotherapy to more than 25% of estimated bone marrow reserve
  • No concurrent external beam radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from all prior therapy
  • At least 4 weeks since prior immunosuppressants
  • No other concurrent investigational drugs
  • No other concurrent anti-cancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031642

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069211, UNMC-535-00, NCI-V02-1691
Study First Received: March 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00031642  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle 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

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Immunoglobulins
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Antibodies
Burkitt Lymphoma
B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009