Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma
29. september 2009 oppdatert av: Favrille
Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Studieoversikt
Detaljert beskrivelse
The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.
Secondary objectives are the determination of overall objective response rate, duration of response and time to progression.
B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface.
Each B-cell harbors a unique genetic sequence used in production of unique Id protein.
No normal B-cells possess that Id on their cell surface.
Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL.
Many of the antigens expressed by tumors (including Id) are only weak immunogens.
To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein.
keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein.
For vaccines which produce primarily an antibody response, there is a concern that combining immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would blunt any antibody response.
For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine.
GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.
T-cell response to both the patient's Idiotype and KLH will be measured during this trial.
Studietype
Intervensjonell
Registrering
90
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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La Jolla, California, Forente stater, 92093
- University of California, San Diego
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Los Angeles, California, Forente stater, 90048
- Tower Hematology Oncology Medical Group
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San Diego, California, Forente stater, 92123
- Oncology Associates of San Diego
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San Francisco, California, Forente stater, 94143
- University California, San Francisco
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Florida
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Jacksonville, Florida, Forente stater, 32209
- University of Florida, Jacksonville
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Tampa, Florida, Forente stater, 33612
- H. Lee Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinical Foundation
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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New York
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Bronx, New York, Forente stater, 10466
- New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Oncology/Hematology Care Clinical Cancer Institute
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals of Cleveland Case Western, Ireland Cancer Center
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- The Sarah Cannon Cancer Center
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Virginia
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Charlottesville, Virginia, Forente stater, 22902
- University of Virginia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria
- 18 years of age or older
- Patients that are treatment naive OR
- Relapsed or refractory following chemotherapy OR
- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been given as second-line therapy following an initial response to chemotherapy or in combination with chemotherapy for initial therapy of their disease.
- Tumor accessible for biopsy or previously existing recent biopsy material
- Measurable disease after node biopsy
- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
- Performance status (ECOG) of 0, 1 or 2
- Absolute Granulocyte count > 1,000/mm3
- Platelets > 100,000/mm3
- Total Bilirubin <2 mg/dL
- AST and ALT <2x Upper Limit of Normal
- Creatinine < 1.5 mg/dL
Exclusion Criteria
- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or PR are considered to be refractory
- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment regimens)
- Treatment w/Fludarabine within 9 months of study entry
- Patients with > 5,000 lymphocytes
- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients whose idiotype has changed are eligible for retreatment with new idiotype)
- Concurrent immunosuppressive therapy (high-dose steroids; ect.)
- Known history of CNS lymphoma or meningeal lymphomatosis
- HIV positive
- Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans), congestive heart failure, or active uncontrolled bacterial, viral or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
- Prior malignancy (excluding non-melanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for >2 years
- Treatment with an investigational drug within 8 weeks prior to study entry
- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving study treatment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2002
Datoer for studieregistrering
Først innsendt
15. juli 2002
Først innsendt som oppfylte QC-kriteriene
16. juli 2002
Først lagt ut (Anslag)
17. juli 2002
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. september 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. september 2009
Sist bekreftet
1. oktober 2004
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FavId-04
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