- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00012207
Biological Therapy After Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the safety and toxicity of cellular immunotherapy with autologous CD8+ cytotoxic T-lymphocyte clones after chemotherapy comprising cyclophosphamide, vincristine, and prednisone in patients with relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma.
Secondary
- Determine the duration of in vivo persistence of adoptively transferred CD20-specific CD8+ cytotoxic T-lymphocyte clones in the absence and presence of subcutaneous interleukin-2 in these patients.
- Assess the trafficking of CD8+ cytotoxic T-lymphocyte clones to lymph nodes in these patients treated with this regimen.
- Determine immune response and tumor response in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
- Leukapheresis: Patients undergo leukapheresis. Selected CD20-specific CD8+ cells are cultured to expand the cytotoxic T lymphocytes (CTL), which are then cloned.
- Chemotherapy:
Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1. Courses repeat every 3-4 weeks for a total of 6 courses.
- Immune cell infusion:
Beginning 4 weeks after the last course of chemotherapy (and lymph nodes ≤ 5 cm diameter or ≤ 5,000 circulating CD20+ lymphocytes/mm^3), patients receive autologous CD8+ CTL clones IV over 30 minutes. Courses repeat every 2-5 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 14 days, beginning 2 hours after the last infusion of CD8+ CTL clones.
After course 2 or 3 of immune cells, all patients undergo surgical lymph node biopsy to determine if immune cells are moving to the lymph nodes.
Patients are followed monthly for 1 year and then annually for 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 years.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
California
-
Duarte, California, Verenigde Staten, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Washington
-
Seattle, Washington, Verenigde Staten, 98195
- University of Washington School of Medicine
-
Seattle, Washington, Verenigde Staten, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma
Indolent B-cell lymphomas including any of the following subtypes:
- Follicular lymphoma (grade I, II, or III)
- Small lymphocytic lymphoma or chronic lymphocytic leukemia
- Marginal zone lymphoma (splenic, nodal, and extra-nodal)
- Lymphoplasmacytoid lymphoma
- Ineligible for or unwilling to participate in other FHCRC/UWMC protocols
- Serological evidence of prior exposure to Epstein-Barr virus
- Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node biopsy, and nuclear medicine imaging
- Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to < 5 cm in diameter or circulating B lymphocyte counts to < 5,000/mm^3
- No pulmonary involvement
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- At least 90 days
Hematopoietic:
- Not specified
Hepatic:
- No active hepatitis B infection
Renal:
- Not specified
Other:
- No HIV positivity
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of hypersensitivity reactions to murine proteins
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 months since prior rituximab, tositumomab, or ibritumomab
- No prior allogeneic stem cell transplantation
- No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products)
Chemotherapy:
- At least 2 years since prior fludarabine or cladribine
- At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
- No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 4 weeks since prior immunosuppressive therapy and recovered
- No concurrent pentoxifylline
- No other concurrent investigational agents
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
---|
Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr
|
Secundaire uitkomstmaten
Uitkomstmaat |
---|
Duration of in vivo persistence of adoptively transferred CD20-specific CD8+ T cell clones by flow cytometry and quantitative polymerase chain reaction (qPCR) during each infusion, weekly for 4 weeks, and then monthly for a year
|
Trafficking of CD8+ CD20-specific T cell clones to lymph nodes by Gamma camera imaging during each infusion, weekly for 4 weeks, and then monthly for a year
|
Development of host anti-scFvFc:zeta (and anti-NeoR) immune responses by ELISA and chromium release assays during each infusion, weekly for 4 weeks, and then monthly for a year
|
Tumor responses to cyclophosphamide, vincristine, and prednisone (CVP) and to cytotoxic T-lymphocyte (CTL) infusions by Cheson criteria during each infusion, weekly for 4 weeks, and then monthly for a year
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Oliver W. Press, MD, PhD, Fred Hutchinson Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Anti-hiv-middelen
- Antiretrovirale middelen
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Antineoplastische middelen, fytogeen
- Aldesleukine
- Cyclofosfamide
- Prednison
- Vincristine
Andere studie-ID-nummers
- 1503.00
- FHCRC-1503.00
- NCI-G01-1921
- CDR0000068494 (Register-ID: PDQ)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op aldesleukine
-
Onur Boyman, MDVoltooidLupus erythematosus, systemischZwitserland
-
Carman GiacomantonioNova Scotia Health AuthorityIngetrokkenCutaan gemetastaseerd melanoom
-
Cambridge University Hospitals NHS Foundation TrustJuvenile Diabetes Research Foundation; Wellcome Trust; University of Cambridge; National...VoltooidDiabetes type 1Verenigd Koninkrijk
-
Christian HinrichsNational Cancer Institute (NCI); Cancer Immunology and Metabolism Center of Excellence...WervingBaarmoederhalskanker | Borstkanker | Maagkanker | LongkankerVerenigde Staten
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actief, niet wervendSarcoom | Gemetastaseerd melanoom | Gemetastaseerde niercelkanker | Stadium IV huidmelanoom AJCC v6 en v7 | Stadium IV Osteosarcoom AJCC v7 | Gemetastaseerd osteosarcoom | Stadium IV niercelkanker AJCC v7 | Gemetastaseerd maligne neoplasma in de longVerenigde Staten
-
Dana-Farber Cancer InstituteWervingAcute myeloïde leukemie | Myelodysplastische syndromen | Leukemie | Leukemie, myeloïde | Myeloproliferatieve aandoeningen | Myeloproliferatief neoplasmaVerenigde Staten
-
The Methodist Hospital Research InstituteWerving
-
Tongji HospitalWervingVaste tumor | Uitgezaaide kanker | HerhalingstumorChina
-
The Methodist Hospital Research InstituteActief, niet wervend
-
Masonic Cancer Center, University of MinnesotaVoltooid