Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: rituximab (Biological); cytarabine (Drug); liposomal cytarabine (Drug); methotrexate (Drug); yttrium Y 90 ibritumomab tiuxetan (Radiation)
Phase: Phase 2
Status: Recruiting
Sponsored by: Beth Israel Deaconess Medical Center Official(s) and/or principal investigator(s): Robin Joyce, MD, Study Chair, Affiliation: Beth Israel Deaconess Medical Center
Summary
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab,
can locate cancer cells and either kill them or deliver radioactive cancer-killing
substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan
with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab
tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large
B-cell non-Hodgkin's lymphoma.
Clinical Details
Official title: Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Study design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeksEvent-free survival Overall survival
Detailed description:
OBJECTIVES:
- Determine the best overall response in patients with relapsed or refractory diffuse
large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and
rituximab.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10
minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
- CNS prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT)
methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal)
on days 15 and 29.
- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at
month 6, patients with stable or responding disease receive maintenance therapy
comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy
repeats every 6 months for 2 years (total of 4 courses) in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any
of the following:
- B-cell diffuse large cell variant
- Immunoblastic
- Mediastinal (thymic) large cell
- T-cell/histiocyte-rich
- Anaplastic large B-cell
- Intravascular large B-cell
- Lymphomatoid granulomatosis
- Relapsed or refractory disease after at least 1 prior chemotherapy regimen and
requires further treatment
- Relapsed disease, defined as the following:
- Appearance of any new lesion OR increase of at least 50% in the size of a
previously involved site
- 50% increase in greatest diameter of any previously identified node greater
than 1 cm in the short axis OR in the sum of the perpendicular diameter
(SPD) of more than 1 node
- Progressive disease, defined as the following:
- 50% increase from nadir in the SPD of any previously identified abnormal
node
- Appearance of any new lesion during or at the end of therapy
- CD20-positive disease by immunohistochemistry
- Bidimensionally measurable disease
- At least 1 lesion at least 2. 0 cm by CT scan
- Less than 25% bone marrow involvement by lymphoma
- No transformed lymphoma from indolent to aggressive
- No HIV- or AIDS-related lymphoma
- No hypocellular bone marrow
- No marked reduction in bone marrow precursors of 1 or more cell lines (e. g.,
granulocytic, megakaryocytic, or erythroid)
- No CNS lymphoma
- Ineligible for myeloablative therapy OR refused transplantation
- Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational
protocols
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic
lymphoma)
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2. 0 mg/dL
Renal
- Creatinine no greater than 2. 0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after study
participation
- No concurrent serious nonmalignant disease or infection that would preclude study
participation
- No human antimurine antibody reactivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior autologous bone marrow transplantation
- No prior peripheral blood stem cell rescue
- No prior failed stem cell collection
- Prior rituximab within the past 90 days allowed provided patient has
fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid
disease in at least 1 lesion
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- No prior radioimmunotherapy
- No prior external beam radiotherapy (involved field or regional) to more than 25% of
active bone marrow
Surgery
- More than 4 weeks since prior major surgery (except diagnostic surgery)
Other
- Recovered from all prior therapy
- More than 4 weeks since prior therapy for lymphoma
- More than 8 weeks since prior phase II investigational drugs
- No other concurrent antineoplastic therapy
Locations and Contacts
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting Clinical Trials Office - Beth Israel Deaconess Medical Center, Phone: 617-667-9925
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont 05401, United States; Recruiting Clinical Trials Office - Fletcher Allen Heakth Care, Phone: 802-656-8990
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2003
Last updated: July 7, 2009
|