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
60 Years
80 Years
Both
Lymphoma
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival measured continuously
Outcome Time Frame:
from date of transplant through date of death
Safety Issue:
No
Principal Investigator
Ajay K. Gopal, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1366.00
NCT ID:
NCT00073931
Start Date:
October 1999
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
