Clincosm LogoSign in Get a demo

Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma

Sponsor
US Oncology Research (Industry)
Overall Status
Terminated
CT.gov ID
NCT00250861
Collaborator
Chiron Corporation (Industry), Fred Hutchinson Cancer Center (Other)
110
Enrollment
21
Locations
22
Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to find out if treatment with rituximab in combination with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as well as determining what other effects (good and bad) this drug combination has on NHL. Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by itself to treat NHL.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for CD20 Positive Aggressive Non-Hodgkin's Lymphoma Following High Dose Therapy With Autologous PBSC Rescue
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    INCLUSION CRITERIA:

    A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:

    • Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma according to REAL classification - only B-cell lymphomas are permitted.

    • ECOG performance status 0-1.

    • Previously histological documented CD20 +NHL.

    • Is greater than 18 years of age.

    • Is 30-100 days from autologous peripheral blood stem cell transplant.

    • Must meet laboratory values (see protocol for values): Absolute neutrophils, hemoglobin and platelets.

    • Has a negative serum pregnancy test within 7 days prior to trial registration (only for female patients of childbearing potential).

    • If fertile, patient (male or female) has agreed to use physician-approved method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.

    • Has signed a Patient Informed Consent Form.

    • Has signed a Patient Authorization Form (HIPAA).

    EXCLUSION CRITERIA:
    Patients will be taken off treatment if any of the following occur:

    • ECOG PS >2.

    • A history of hypersensitivity to study drugs, or any component thereof, or anaphylactic history to murine protein.

    • Manifested cardiac complications during transplant, including arrthymias, congestive heart failure, angina, or myocardial infarct, or had a decreased LVEF to <45% prior to transplant

    • On systemic corticosteroids.

    • Diffusion capacity <60% (corrected) and has decreased 30% or more following transplant

    • Documented disease progression (See Section 10.1.6 for definition).

    • Active infection, and/or is known to be seropositive for hepatitis B, hepatitis C, or HIV

    • Pericardial effusion, pleural effusions, or ascites.

    • A history of very aggressive NHL, such as Burkitt's or atypical Burkitt's lymphoma

    • Receiving concurrent immunotherapy or rituximab therapy.

    • Previously received a solid organ transplant.

    • History of CNS involvement.

    • A serious uncontrolled intercurrent medical or psychiatric illness, including serious infection

    • A history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.

    • A pregnant or nursing woman.

    • Unable to comply with requirements of study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Center-Midtown Denver Colorado United States 80218
    2 Hematology Oncology Associates of IL Chicago Illinois United States 60611
    3 Cancer Care & Hematology Specialists of Chicagoland Niles Illinois United States 60714
    4 Minnesota Oncology Hematology, PA Minneapolis Minnesota United States 55404
    5 Kansas City Cancer Centers-Central Kansas Missouri United States 64111
    6 Greater Dayton Cancer Center Kettering Ohio United States 45409
    7 Cancer Centers of the Carolinas Greenville South Carolina United States 29615
    8 Texas Cancer Center Arlington Texas United States 76014
    9 Texas Cancer Center at Medical City Dallas Texas United States 75230
    10 El Paso Cancer Treatment Ctr El Paso Texas United States 79915
    11 San Antonio Tumor & Blood Clinic Fredericksburg Texas United States 78624
    12 Texas Oncology, PA Garland Texas United States 75042
    13 Longview Cancer Center Longview Texas United States 75601
    14 Tyler Cancer Center Tyler Texas United States 75702
    15 Fairfax Northern VA Hem-Onc PC Fairfax Virginia United States 22031
    16 Virginia Oncology Associates Norfolk Virginia United States 23502
    17 Onc and Hem Associates of SW VA, Inc. Salem Virginia United States 24153
    18 Puget Sound Cancer Center-Edmonds Edmonds Washington United States 98026
    19 Pudget Sound Cancer Center-Seattle Seattle Washington United States 98133
    20 Cancer Care Northwest-North Spokane Washington United States 99218
    21 Yakima Valley Mem Hosp/North Star Lodge Yakima Washington United States 98902

    Sponsors and Collaborators

    • US Oncology Research
    • Chiron Corporation
    • Fred Hutchinson Cancer Center

    Investigators

    • Principal Investigator: Stephanie Williams, MD, US Oncology Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00250861
    Other Study ID Numbers:
    • US-I-IL2-04-029
    First Posted:
    Nov 8, 2005
    Last Update Posted:
    Apr 21, 2008
    Last Verified:
    Apr 1, 2008
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Aldesleukin
    Rituximab

    Study Results

    No Results Posted as of Apr 21, 2008