Status:
COMPLETED
Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
60-80 years
Phase:
PHASE2
Brief Summary
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. Combini...
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00073931
Start Date
October 1 1999
End Date
July 1 2014
Last Update
February 5 2015
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024