NCT00010192

Brief Summary

Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

February 2, 2001

Last Update Submit

June 5, 2013

Conditions

B-cell Adult Acute Lymphoblastic LeukemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaSplenic Marginal Zone LymphomaStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Small Lymphocytic LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0

    Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.

    2 weeks

Study Arms (1)

Treatment (rituximab and aldesleukin)

EXPERIMENTAL

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.

Biological: rituximabBiological: aldesleukinOther: laboratory biomarker analysisOther: pharmacological study

Interventions

rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (rituximab and aldesleukin)
aldesleukinBIOLOGICAL

Given SC

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2
Treatment (rituximab and aldesleukin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (rituximab and aldesleukin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (rituximab and aldesleukin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
  • Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
  • Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
  • No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
  • Measurable or evaluable disease
  • Must have failed standard curative therapy
  • No CNS or leptomeningeal metastasis
  • Performance status - Karnofsky 70-100%
  • Performance status - ECOG 0-1
  • At least 4 months
  • Absolute neutrophil count at least 1,000/mm\^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)
  • Platelet count at least 50,000/mm\^3
  • AST no greater than upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

RituximabaldesleukinInterleukin-2

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesLymphokinesBiological Factors

Study Officials

  • Pierluigi Porcu

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Primary Completion

January 1, 2003

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)