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

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma

Intervention: Rituximab (Drug); Aldesleukin (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Stephanie Williams, MD, Principal Investigator, Affiliation: US Oncology Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Rocky Mountain Cancer Center-Midtown, Denver, Colorado 80218, United States

Hematology Oncology Associates of IL, Chicago, Illinois 60611, United States

Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois 60714, United States

Minnesota Oncology Hematology, PA, Minneapolis, Minnesota 55404, United States

Kansas City Cancer Centers-Central, Kansas, Missouri 64111, United States

Greater Dayton Cancer Center, Kettering, Ohio 45409, United States

Cancer Centers of the Carolinas, Greenville, South Carolina 29615, United States

Texas Cancer Center, Arlington, Texas 76014, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230, United States

El Paso Cancer Treatment Ctr, El Paso, Texas 79915, United States

San Antonio Tumor & Blood Clinic, Fredericksburg, Texas 78624, United States

Texas Oncology, PA, Garland, Texas 75042, United States

Longview Cancer Center, Longview, Texas 75601, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Fairfax Northern VA Hem-Onc PC, Fairfax, Virginia 22031, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Onc and Hem Associates of SW VA, Inc., Salem, Virginia 24153, United States

Puget Sound Cancer Center-Edmonds, Edmonds, Washington 98026, United States

Pudget Sound Cancer Center-Seattle, Seattle, Washington 98133, United States

Cancer Care Northwest-North, Spokane, Washington 99218, United States

Yakima Valley Mem Hosp/North Star Lodge, Yakima, Washington 98902, United States

Additional Information

Starting date: October 2005
Last updated: April 17, 2008

Page last updated: August 23, 2015

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