Status:
COMPLETED
Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of fludarabine (fludarabine phosphate) when given together with iodine I 131 tositumomab in treating older patients who are undergoing an auto...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximally tolerated dose of fludarabine that can be combined with 131I-anti-CD20 (iodine I 131 tositumomab) delivering =\< 27Gy to critical normal organs follow...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients
- Creatinine (Cr) \< 2.0
- Bilirubin \< 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, whom may have a total bilirubin above 1.5 mg/dL
- All patients eligible for therapeutic study must have (\>= 2x10\^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved, or this number of cells harvested from a syngeneic donor
- Patients must have an expected survival of \> 60 days and must be free of major infection
- DONOR: Syngeneic donors must be confirmed syngeneic by ABO typing, human leukocyte antigen (HLA) typing, and variable number tandem repeat (VNTR) analysis
- DONOR: Syngeneic donors must meet eligibility under Standard Practice Guidelines/Standard Treatment
Exclusion
- Circulating anti-mouse antibody (HAMA) (to be determined before both dosimetry and therapy)
- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose
- Inability to understand or give an informed consent
- Prior radiation \> 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, \> 25% of red marrow)
- Central nervous system lymphoma
- Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusing capacity (DLCO) \< 50% predicted, patient on supplemental oxygen, acquired Immunodeficiency syndrome \[AIDS\], etc.)
- Pregnancy
- Prior bone marrow or stem cell transplant
- South West Oncology Group (SWOG) performance status \>= 2
- Unable to perform self-care during radiation isolation
- Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma/well differentiated lymphocytic lymphoma
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00110071
Start Date
January 1 2005
Last Update
August 6 2014
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109