Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

NCT00110149 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 2004P000044CDR0000409723NCI-2011-02445
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

contiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; stage I grade 1 follicular lymphoma; stage III grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; stage I grade 2 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; contiguous stage II marginal zone lymphoma; noncontiguous stage II marginal zone lymphoma; splenic marginal zone lymphoma; stage I marginal zone lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

• Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks

  INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.

  14 weeks

• EFS

  Event = Death, second malignancy , disease progression.

  1 year

Study Arms (1)

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

EXPERIMENTAL

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

yttrium Y 90 ibritumomab tiuxetan RADIATION

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes: * Grade1 or 2 follicular lymphoma * Small lymphocytic lymphoma (SLL) * Marginal zone B-cell lymphoma * CD20-positive disease confirmed by immunohistochemistry or flow cytometry * Bidimensionally measurable disease * At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan * Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks * No clinically significant impaired bone marrow reserve as evidenced by any of the following: * Hypocellular marrow, as evidenced by 1 of the following: * ≤ 15% cellularity * Marked reduction in bone marrow precursors * Platelet count \< 100,000/mm\^3 * Absolute neutrophil count \< 1,500/mm\^3 * History of failed stem cell collection * Prior myeloablative therapy * No greater than 5,000/mm\^3 circulating tumor cells in peripheral blood * Requires antilymphoma therapy, as indicated by any of the following: * Systemic symptoms * B symptoms * Cytopenias * Malaise * Organ compromise * Discomfort * Pain * Disfigurement * Rapidly progressive disease * Undue anxiety related to not receiving treatment * No transformation to intermediate or high-grade NHL * No known brain metastases or CNS involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 OR * WHO 0-2 OR * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * See Disease Characteristics * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Lymphocyte count \< 5,000/mm\^3 (for patients with SLL ) Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 2.0 mg/dL OR * Creatinine clearance \> 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Immunologic * No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins) * No ongoing or active infection * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 1 year after study treatment * No other active malignancy except non-melanoma skin cancer * No other serious nonmalignant disease that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior pegfilgrastim * More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional) Surgery * More than 4 weeks since prior major surgery except diagnostic surgery Other * No prior systemic antilymphoma therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy * No other concurrent investigational agents * No other concurrent antilymphoma therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This trial was stopped abruptly when the makers of the investigational agent sold the company and the agent was not available for a significant period of time. Attempts were made to follow all patients for 12 months after treatment.

Results Point of Contact

• Title: Robin Joyce, MD
• Organization: BIDMC

rjoyce@bidmc.harvard.edu

617-667-9920

Study Officials

• Robin Joyce, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: May 1, 2004
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2015
• Last Updated: November 21, 2017
• Results First Posted: November 21, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)