Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation
- Conditions
- Lymphoma
- Registration Number
- NCT00031642
- Lead Sponsor
- University of Nebraska
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
-
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
o 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
o More than 2 cm bidimensionally
-
19 years of age and over
-
Performance status WHO 0-2
-
Life expectancy at least 3 months
-
Absolute neutrophil count greater than 1,500/mm^3
-
Platelet count greater than 150,000/mm^3
-
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)
-
Creatinine less than 2.0 mg/dL
-
Fertile patients must use effective contraception during and for 6 months after study therapy
-
HIV negative
-
At least 4 weeks since prior growth factors
-
At least 4 weeks since prior biologic therapy
-
At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
-
At least 4 weeks since prior radiotherapy
-
Recovered from all prior therapy
-
At least 4 weeks since prior immunosuppressants
- No active CNS lymphoma
- No HIV- or AIDS-related lymphoma
- No transfusion dependency
- No active obstructive hydronephrosis
- Not pregnant or nursing/negative pregnancy test
- No active infection requiring oral or IV antibiotics
- No human antimurine antibody positivity
- No other major medical problems
- 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
- No prior fludarabine
- No concurrent chemotherapy
- No concurrent steroids except as maintenance for non-cancerous disease
- No prior pelvic radiotherapy
- No prior radiotherapy to more than 25% of estimated bone marrow reserve
- No concurrent external beam radiotherapy
- No other concurrent investigational drugs
- No other concurrent anti-cancer therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum tolerated dose Safety and efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Eppley Cancer Center at University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States