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:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00073931
First received: December 10, 2003
Last updated: March 25, 2013
Last verified: March 2013
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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:
Drug Information available for:
Iodine
Sodium iodide I 131
Iodide
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
Tositumomab
U.S. FDA Resources
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:
Detailed Description:
-
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)
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 25, 2013 |
| 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 May 16, 2013