NCT00033423

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

7.8 years

First QC Date

April 9, 2002

Last Update Submit

December 12, 2013

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL).

    baseline through 4 years

Secondary Outcomes (3)

  • Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen

    baseline through 4 years

  • Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen.

    baseline through 4 years

  • Determine the antitumor response in patients treated with this regimen.

    baseline through 4 years

Study Arms (5)

Cohort 1

EXPERIMENTAL

First radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan

Cohort II

EXPERIMENTAL

Second radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan

Cohort III

EXPERIMENTAL

Third radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan

Cohort IV

EXPERIMENTAL

Fourth radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan

Cohort V

EXPERIMENTAL

MTD radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximabBIOLOGICAL
Cohort 1Cohort IICohort IIICohort IVCohort V
yttrium Y 90 ibritumomab tiuxetanRADIATION
Cohort 1Cohort IICohort IIICohort IVCohort V

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) * Relapsed after prior chemotherapy OR chemotherapy-resistant disease * Failed at least 1 prior chemotherapy regimen * CD20-positive B-cell population in lymph nodes or bone marrow for International Working Formulation A (small lymphocytic lymphoma) and transformed NHL * Bone marrow involvement with lymphoma less than 25% bilaterally * No impaired bone marrow reserve defined as at least 1 of the following criteria: * Prior myeloablative therapies with bone marrow transplantation or peripheral blood stem cell rescue * Platelet count less than 100,000/mm3 * Bone marrow cellularity no greater than 15% * Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) * Failed prior stem cell collection * No CNS lymphoma, chronic lymphocytic lymphoma, or HIV or AIDS-related lymphoma * No diffuse small lymphocytic/marginal zone lymphoma with lymphocyte count greater than 5,000/mm\^3 * No pleural effusion 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: * 19 and over Performance status: * WHO 0-2 Life expectancy: * At least 6 months Hematopoietic: * See Disease Characteristics * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hematocrit greater than 30% * Hemoglobin greater than 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No anti-murine antibody reactivity if prior exposure to murine antibodies or proteins * No other primary malignancy * No other serious nonmalignant disease or infection that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior radioimmunotherapy * Prior rituximab allowed if more than 6 months to progression after an objective response * At least 6 weeks since prior rituximab * At least 3 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * Recovered from prior immunotherapy Chemotherapy: * See Disease Characteristics * No prior fludarabine * At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy Endocrine therapy: * At least 3 weeks since prior anticancer endocrine therapy * No concurrent high-dose systemic corticosteroids (e.g., 50 mg or more of prednisone as a single dose or 50 mg or less of prednisone for more than 6 doses) Radiotherapy: * No prior radiotherapy to more than 25% of active bone marrow (involved field or regional) * At least 3 weeks since prior anticancer radiotherapy and recovered Surgery: * At least 4 weeks since prior surgery (except diagnostic surgery) and recovered Other: * No other concurrent anticancer therapy * Concurrent oral anticoagulant therapy allowed if platelet count is at least 30,000/mm3

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

Sponsors & Collaborators

Study Sites (3)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, 94305, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Forero-Torres A, Besh S, Knox S, et al.: Higher doses of Rituxan alter pharmacokinetics and biodistribution of Zevalin but may increase responses; a preliminary report of a phase I study of Zevalin using a modified treatment regimen for relapsed or refractory CD20+ B-Cell follicular/transformed non-Hodgkins lymphoma. [Abstract] Blood 102 (11 Pt 1): A-1483, 2003.

    RESULT

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andres Forero-Torres, MD, CSU

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

US(3)