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

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00073931

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	Drug: filgrastim Drug: sargramostim Drug: tositumomab and iodine I 131 tositumomab Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics: Bone Marrow Transplantation Cancer Lymphoma

Drug Information available for: Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Iodine Cadexomer iodine Sodium iodide I 131 Tositumomab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

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

Primary Outcome Measures:

Disease-free survival measured continuously [ Designated as safety issue: No ]

Study Start Date:

October 1999

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Ajay K. Gopal, MD

Fred Hutchinson Cancer Research Center

More Information

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

Publications of Results:

Gopal AK, Rajendran JG, Gooley TA, Pagel JM, Fisher DR, Petersdorf SH, Maloney DG, Eary JF, Appelbaum FR, Press OW. High-dose [131I]tositumomab (anti-CD20) radioimmunotherapy and autologous hematopoietic stem-cell transplantation for adults > or = 60 years old with relapsed or refractory B-cell lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1396-402. Epub 2007 Feb 20.

Study ID Numbers:	CDR0000341125, FHCRC-1366.00
Study First Received:	December 10, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00073931
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Iodine-131 anti-B1 antibody
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoblastic lymphoma
Mantle cell lymphoma
Lymphoma, large-cell, immunoblastic
Recurrence
Antibodies, Monoclonal
Lymphoma, large-cell

Burkitt's lymphoma
Lymphatic Diseases
Antibodies
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Iodine
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Trace Elements
Pharmacologic Actions
Anti-Infective Agents, Local
Neoplasms
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 15, 2009