Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma That Has Relapsed After High-Dose Chemotherapy and Autologous Stem Cell Transplantation
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ClinicalTrials.gov Identifier: NCT00031642 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: December 17, 2013
|
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RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances.
PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan | Phase 1 Phase 2 |
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
- Determine the safety and efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan (IDEC-Y2B8).
- Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity.
- Phase II: Once the MTD is determined, 58 additional patients are treated at that dose level as in phase I.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be accrued for this study within 2 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma |
Study Start Date : | January 2002 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | March 2008 |

- Maximum tolerated dose
- Safety and efficacy

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation
-
Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks
- Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis
-
CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following:
- Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
- Flow cytometry studies
-
Measurable disease
- More than 2 cm bidimensionally
- No active CNS lymphoma
- No HIV- or AIDS-related lymphoma
PATIENT CHARACTERISTICS:
Age:
- 19 and over
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 150,000/mm^3
- No transfusion dependency
Hepatic:
- Bilirubin less than 2.0 mg/dL
- SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver)
Renal:
- Creatinine less than 2.0 mg/dL
- No active obstructive hydronephrosis
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study therapy
- HIV negative
- No active infection requiring oral or IV antibiotics
- No human antimurine antibody positivity
- No other major medical problems
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior growth factors
- At least 4 weeks since prior biologic therapy
- No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF])
- No prior radioimmunotherapy
- No other concurrent biologic therapy of any kind
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
- No prior fludarabine
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent steroids except as maintenance for non-cancerous disease
Radiotherapy:
- See Biologic therapy
- At least 4 weeks since prior radiotherapy
- No prior pelvic radiotherapy
- No prior radiotherapy to more than 25% of estimated bone marrow reserve
- No concurrent external beam radiotherapy
Surgery:
- Not specified
Other:
- Recovered from all prior therapy
- At least 4 weeks since prior immunosuppressants
- No other concurrent investigational drugs
- No other concurrent anti-cancer therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031642
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 |
Study Chair: | Julie M. Vose, MD | University of Nebraska |
Responsible Party: | Julie M Vose, MD, Professor, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00031642 History of Changes |
Other Study ID Numbers: |
535-00 CDR0000069211 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V02-1691 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | December 17, 2013 |
Last Verified: | December 2013 |
Keywords provided by Julie M Vose, MD, University of Nebraska:
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma 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 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |