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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Aldesleukin
Sponsored by
US Oncology Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Rocky Mountain Cancer Center-Midtown
  • Hematology Oncology Associates of IL
  • Cancer Care & Hematology Specialists of Chicagoland
  • Minnesota Oncology Hematology, PA
  • Kansas City Cancer Centers-Central
  • Greater Dayton Cancer Center
  • Cancer Centers of the Carolinas
  • Texas Cancer Center
  • Texas Cancer Center at Medical City
  • El Paso Cancer Treatment Ctr
  • San Antonio Tumor & Blood Clinic
  • Texas Oncology, PA
  • Longview Cancer Center
  • Tyler Cancer Center
  • Fairfax Northern VA Hem-Onc PC
  • Virginia Oncology Associates
  • Onc and Hem Associates of SW VA, Inc.
  • Puget Sound Cancer Center-Edmonds
  • Pudget Sound Cancer Center-Seattle
  • Cancer Care Northwest-North
  • Yakima Valley Mem Hosp/North Star Lodge

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 7, 2005
Last Updated
April 17, 2008
Sponsor
US Oncology Research
Collaborators
Chiron Corporation, Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00250861
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of enrollment.
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Oncology Research
Collaborators
Chiron Corporation, Fred Hutchinson Cancer Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
Aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Williams, MD
Organizational Affiliation
US Oncology Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Cancer Center-Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Hematology Oncology Associates of IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cancer Care & Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Kansas City Cancer Centers-Central
City
Kansas
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Texas Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Cancer Center at Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
El Paso Cancer Treatment Ctr
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
San Antonio Tumor & Blood Clinic
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
Facility Name
Texas Oncology, PA
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Fairfax Northern VA Hem-Onc PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Onc and Hem Associates of SW VA, Inc.
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Puget Sound Cancer Center-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Pudget Sound Cancer Center-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Cancer Care Northwest-North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Yakima Valley Mem Hosp/North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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