Non Hodgkin Lymphoma Clinical Trial

Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin’s Lymphoma

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells.

PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.

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Full Description

OBJECTIVES:

Primary

Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.

Secondary

Compare response rate improvement in patients treated with these regimens.
Compare overall complete response rate in patients treated with these regimens.
Compare duration of response in patients treated with these regimens.
Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior treatment (yes vs no) and response to rituximab during study (complete response [CR] or partial response [PR] vs stable disease [SD]).

All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of rituximab, patients are assessed for response. Patients with progressive disease are removed from the study and do not undergo randomization. Patients with a CR, PR, or SD are randomized to 1 of 2 treatment arms.

Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4.

In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease. After the first 6 months, patients with a CR, PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for 1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease progression.

Patients are followed every 3 months for 2 years and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

Grade 1, 2, or 3

Meets 1 of the following criteria for treatment with rituximab:

Treatment naïve
Relapsed or refractory disease after prior chemotherapy
Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
Measurable or evaluable disease after tumor tissue procurement for vaccine production

No more than 2 prior treatment regimens for NHL

Single regimens include any of the following:

Maintenance rituximab
Rituximab administered once weekly for 8 courses
Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab* NOTE: *CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
No history of CNS lymphoma or meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3 (unless related to bone marrow involvement by lymphoma)
Hemoglobin ≥ 10g/dL

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No congestive heart failure

Pulmonary

No compromised pulmonary function

Immunologic

HIV negative
No prior allergic response to GM-CSF
No active bacterial, viral, or fungal infection

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric disorder that would preclude study participation
No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other serious nonmalignant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
See Chemotherapy
At least 4 weeks since prior immunotherapy
No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
No prior autologous or allogeneic stem cell transplantation
No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)

Chemotherapy

See Disease Characteristics
At least 4 weeks since prior chemotherapy
More than 9 months since prior fludarabine
More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone [CVP]/rituximab)
No more than 6 total prior treatment courses with fludarabine

Endocrine therapy

No concurrent steroids for allergic reaction to sargramostim (GM-CSF)

Radiotherapy

See Biologic therapy
At least 4 weeks since prior radiotherapy

Surgery

Not specified

Other

At least 4 weeks since prior experimental therapy
No concurrent systemic immunosuppressive therapy
No other concurrent anti-lymphoma therapy

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Study ID:

NCT00089115

Recruitment Status:

Terminated

Sponsor:

Favrille

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There are 60 Locations for this study

See Locations Near You

Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Tower Cancer Research Foundation
Beverly Hills California, 90211, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego California, 92120, United States
Sharp Memorial Hospital Cancer Center
San Diego California, 92123, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94143, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford California, 94305, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver Colorado, 80218, United States
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center
Newark Delaware, 19713, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Center for Hematology-Oncology - Boca Raton
Boca Raton Florida, 33486, United States
University of Florida Health Science Center - Jacksonville
Jacksonville Florida, 32209, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
North Idaho Cancer Center
Coeur d'Alene Idaho, 83814, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59802, United States
New Mexico Cancer Center
Albuquerque New Mexico, 87109, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York New York, 10003, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Mid Dakota Clinic, P. C.
Bismarck North Dakota, 58502, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo North Dakota, 58122, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45219, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
Kaiser Permanente Medical Office - Interstate Medical Office Central
Portland Oregon, 97227, United States
Cancer Institute at Oregon Health and Science University
Portland Oregon, 97239, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Fox Chase-Temple Cancer Center
Philadelphia Pennsylvania, 19111, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville Tennessee, 37203, United States
Baylor University Medical Center - Dallas
Dallas Texas, 75246, United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
Cancer Care Network of South Texas
San Antonio Texas, 78229, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98104, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima Washington, 98902, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Study ID:

NCT00089115

Recruitment Status:

Terminated

Sponsor:


Favrille

How clear is this clinincal trial information?

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