NCT00003356

Brief Summary

RATIONALE: Monoclonal antibodies 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. PURPOSE: Phase I/II trial to study the effectiveness of combining rituximab and interleukin-2 intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Nov 1997

Typical duration for phase_1 lymphoma

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

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

March 22, 2004

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

October 14, 2013

Conditions

Lymphoma

Keywords

stage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

aldesleukinBIOLOGICAL
rituximabBIOLOGICAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage II-IV low-grade, mantle cell, or follicular B-cell lymphoma Stage I disease is eligible only if radiotherapy is not considered feasible due to location of disease or previous radiation treatments No chronic lymphocytic lymphoma No small lymphocytic lymphoma with lymphocyte count greater than 5,000/mm3 Must be either first-line therapy or no more than 4 relapses after standard therapies, including chemotherapy, radiotherapy, autologous bone marrow transplantation, and/or immunotherapy Eligible if refractory to first treatment with a standard therapy Patients refractory to autologous bone marrow transplantation (ABMT) or relapsed after ABMT are eligible Patients with low-grade or follicular lymphoma must have failed at least one chemotherapy regimen Patients with mantle cell lymphoma are eligible even if no prior treatment Bidimensionally measurable disease Demonstrable monoclonal CD20-positive B-cell population in lymph nodes or bone marrow No prior diagnosis of intermediate or high-grade non-Hodgkin's lymphoma No CNS, pericardial, pleural, or peritoneal involvement by lymphoma No AIDS-related lymphoma No pleural effusion No ascites 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: 18 to 75 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine clearance at least 65 mL/min Cardiovascular: See Disease Characteristics No pericardial effusion No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months Other: No active, uncontrolled bacterial, viral, or fungal infection No active opportunistic infection No active inflammatory arthritis (excluding degenerative joint disease) No known hypersensitivity to interleukin-2 No history of an autoimmune disorder No history of seizure disorder No other primary malignancy in the past 5 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior radioimmunotherapy At least 6 months since prior autologous bone marrow transplantation and recovered At least 4 weeks since prior colony-stimulating factors or epoetin alfa At least 3 weeks since prior immunotherapy and recovered No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: At least 3 weeks since prior corticosteroids No corticosteroids during or for 8 weeks after study Radiotherapy: See Disease Characteristics See Biologic therapy At least 3 weeks since prior radiotherapy and recovered Surgery: Not a recipient of an allogeneic organ transplantation, unless organ is no longer functional At least 4 weeks since any prior major surgery (except diagnostic surgery) and recovered

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

Sponsors & Collaborators

Study Sites (1)

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

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

Interventions

aldesleukinRituximab

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

  • Joseph D. Rosenblatt, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 22, 2004

Study Start

November 1, 1997

Primary Completion

May 1, 2002

Study Completion

May 1, 2002

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

US(1)