Clinical trial NCT00250861: Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Chiron Corporation
name: Fred Hutchinson Cancer Center
First posted: 2005-11-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center-Midtown
state: Colorado
city: Chicago
country: United States
facility: Hematology Oncology Associates of IL
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Kansas
country: United States
facility: Kansas City Cancer Centers-Central
state: Missouri
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr
state: Texas
city: Fredericksburg
country: United States
facility: San Antonio Tumor & Blood Clinic
state: Texas
city: Garland
country: United States
facility: Texas Oncology, PA
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax Northern VA Hem-Onc PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Associates of SW VA, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center-Edmonds
state: Washington
city: Seattle
country: United States
facility: Pudget Sound Cancer Center-Seattle
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest-North
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Mem Hosp/North Star Lodge
state: Washington
Study officials:
affiliation: US Oncology Research
name: Stephanie Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: