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

Stopped early · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00250861

Run by

US Oncology Research

People needed

110

Starts

2005-10-01

Expected to finish

2007-08-01

Last updated by the study team

2008-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Rocky Mountain Cancer Center-Midtown — Denver, Colorado, United States
• Hematology Oncology Associates of IL — Chicago, Illinois, United States
• Cancer Care & Hematology Specialists of Chicagoland — Niles, Illinois, United States
• Minnesota Oncology Hematology, PA — Minneapolis, Minnesota, United States
• Kansas City Cancer Centers-Central — Kansas City, Missouri, United States
• Greater Dayton Cancer Center — Kettering, Ohio, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Texas Cancer Center — Arlington, Texas, United States
• Texas Cancer Center at Medical City — Dallas, Texas, United States
• El Paso Cancer Treatment Ctr — El Paso, Texas, United States
• San Antonio Tumor & Blood Clinic — Fredericksburg, Texas, United States
• Texas Oncology, PA — Garland, Texas, United States
• Longview Cancer Center — Longview, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Fairfax Northern VA Hem-Onc PC — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Onc and Hem Associates of SW VA, Inc. — Salem, Virginia, United States
• Puget Sound Cancer Center-Edmonds — Edmonds, Washington, United States
• Pudget Sound Cancer Center-Seattle — Seattle, Washington, United States
• Cancer Care Northwest-North — Spokane, Washington, United States
• Yakima Valley Mem Hosp/North Star Lodge — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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