Wegener's Granulomatosis |
Wegener Granulomatosis |
Clinical Trial: Long-Term Effects of Iodine I131 Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is currently recruiting patients.
Purpose
RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.
PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult lymphomatoid granulomatosis adult non-Hodgkin's lymphoma indolent or aggressive adult non-Hodgkin's lymphoma Quality of Life | Procedure: complications of therapy assessment/management Procedure: quality-of-life assessment Procedure: supportive care/therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphatic Diseases; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Long-Term Follow-up Study of Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma Previously Treated With Iodine I131 Tositumomab Followed By Autologous Bone Marrow or Stem Cell Transplantation
OBJECTIVES:
- Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I^131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296, 521, 792, or 915.
- Determine the long-term toxic effects of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a long-term, follow-up study.
Patients undergo physical examinations, blood tests, and immune system assessments every 3 months for 1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at 1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if clinically indicated) annually for up to 10 years.
Quality of life is assessed annually.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of B-cell non-Hodgkin's lymphoma
- Relapsed or refractory disease
- Previously treated with myeloablative doses of iodine I
- tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:
- FHCRC-296
- FHCRC-521
- FHCRC-915
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Location and Contact Information
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States; Recruiting
Oliver W. Press, MD, PhD, Principal Investigator, Fred Hutchinson Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2004
Last Updated: February 4, 2005
Record first received: December 7, 2004
ClinicalTrials.gov Identifier: NCT00098566
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- American Autoimmune Related Diseases Association
- Autoimmune Diseases: An Attack on Self Tissues (National Institute of Allergy and Infectious Diseases)

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