Non Hodgkin Lymphoma Clinical Trial
Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Primary
Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)â„¢ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavIdâ„¢ while enrolled on protocol FAV-ID-06.
Secondary
Determine the response rate and duration of response in patients treated with this regimen.
Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
Determine the time to progression in patients treated with this regimen.
Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.
After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.
PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
Grade 1, 2, or 3
Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavIdâ„¢) while enrolled on protocol FAV-ID-06
Meets 1 of the following criteria:
Received salvage therapy after completion of protocol FAV-ID-06
At least 4 weeks, but no more than 4 months, since prior salvage therapy
Did not receive salvage therapy after completion of protocol FAV-ID-06
At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06
No history of CNS lymphoma OR meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
Cardiovascular
No history of congestive heart failure
Pulmonary
No history of compromised pulmonary function
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No active bacterial, viral, or fungal infection
No psychiatric disorder
No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
No prior allogeneic transplantation*
No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks)
Chemotherapy
No prior purine analogues* (e.g., fludarabine or cladribine)
Endocrine therapy
No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)
Radiotherapy
Not specified
Surgery
Not specified
Other
Recovered from prior salvage therapy
No prior or concurrent immunosuppressive therapy
No prior investigational agents*
No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study
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There are 51 Locations for this study
Birmingham Alabama, 35294, United States
Beverly Hills California, 90211, United States
La Jolla California, 92093, United States
Los Angeles California, 90048, United States
San Diego California, 92120, United States
San Diego California, 92123, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Vallejo California, 94589, United States
Denver Colorado, 80218, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Tampa Florida, 33612, United States
Coeur d'Alene Idaho, 83814, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21204, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Missoula Montana, 59807, United States
Albuquerque New Mexico, 87109, United States
Bronx New York, 10466, United States
Manhasset New York, 11030, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15224, United States
Nashville Tennessee, 37203, United States
San Antonio Texas, 78229, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98104, United States
Yakima Washington, 98902, United States
Madison Wisconsin, 53792, United States
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