Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00073931
First received: December 10, 2003
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Biological: sargramostim
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: tositumomab and iodine I 131 tositumomab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Disease-free survival measured continuously [ Time Frame: from date of transplant through date of death ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 1999
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    5 µg/kg/day subcutaneously
    Other Name: G-CSF
    Biological: sargramostim
    250µg/m2/d subcutaneously
    Other Name: GM-CSF
    Procedure: autologous bone marrow transplantation
    autologous stem cells given via central catheter
    Procedure: peripheral blood stem cell transplantation
    autologous stem cells given via central catheter
    Radiation: tositumomab and iodine I 131 tositumomab
    given intravenously (test dose of 1.7-10 mg/kg tositumomab antibody radiolabeled with ~10 mCi I-131) or via central catheter (therapy dose of 1.7-10 mg/kg tositumomab radiolabeled with individually calculated therapy dose of I-131)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE:

  • Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4.
  • Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma
  • CD20+ disease
  • Failed at least 1 prior standard systemic therapy
  • Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction
  • Tumor burden less than 500 cc by computed tomography or MRI

    • No splenomegaly
  • Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved

    • No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used
    • 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used
  • No CNS lymphoma
  • No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma

PATIENT CHARACTERISTICS:

Age

  • 60 to 80

Performance status

  • SWOG 0-1

Life expectancy

  • More than 60 days

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 1.5 mg/dL

Renal

  • Creatinine less than 2.0 mg/dL

Cardiovascular

  • No active coronary artery disease

Pulmonary

  • FEV_1 at least 70% of expected
  • Vital capacity at least 70% of expected

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Able to perform self-care during radiation isolation
  • No major organ dysfunction
  • No major infection
  • No circulating anti-mouse antibody
  • No other serious medical condition considered to represent contraindications to bone marrow transplantation
  • No competing causes of death that would predict life span to be less than 10 additional years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow or stem cell transplantation

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow)

Surgery

  • Not specified

Other

  • More than 30 days since prior systemic antilymphoma therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073931

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Ajay K. Gopal, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00073931     History of Changes
Other Study ID Numbers: 1366.00, CDR0000341125
Study First Received: December 10, 2003
Last Updated: March 17, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine
Lenograstim
Antibodies, Monoclonal
Iodine-131 anti-B1 antibody
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014