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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 weeks

Event-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

Page last updated: August 23, 2015

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