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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00012298 |
Purpose
RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Biological: recombinant interleukin-11 Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Two Sequential Doses of IDEC-Y2B8 in Patients With Relapsed Low Grade and Follicular Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 73 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-^90Y2B8) followed by a phase II open-label study.
Cohorts of 3-6 patients receive escalating doses of IDEC-^90Y2B8 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, additional patients are accrued to determine the MTD of this radioimmunotherapy with the addition of the prophylactic cytokines, G-CSF and IL-11.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven relapsed or refractory low-grade or follicular CD20+ non-Hodgkin's lymphoma, including 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| Responsible Party: | Thomas E. Witzig, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00012298 History of Changes |
| Other Study ID Numbers: | CDR0000068503, P30CA015083, MC998C, 312 |
| Study First Received: | March 3, 2001 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma Waldenstrom macroglobulinemia recurrent marginal zone lymphoma |
recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal |
Lenograstim Rituximab Oprelvekin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic Antirheumatic Agents |