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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
Studie Overzicht
Gedetailleerde beschrijving
OBJECTIVES Primary
- To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
- To determine feasibility of vaccine administration according to the proposed schedule
- To determine toxicity of vaccination with CD40-activated autologous ALL cells
Secondary
- To assess ALL-specific immunity following vaccination
- To assess the generation of immunity to control antigens
- To develop preliminary information on effect vaccination on tumor response
Studietype
Inschrijving (Werkelijk)
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital Cancer Center
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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
Inclusion Criteria
- B-cell acute lymphoblastic leukemia
- Disease involving at least 30% of bone marrow or circulating blasts
In first relapse with at least 1 of the following high-risk features:
- Age under 1 year at diagnosis
- Age over 18 years at diagnosis
- t(9;22)
- Occurrence of first relapse less than 18 months after diagnosis
- In second relapse or beyond
- Refractory disease
- Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
- Less than 1 year since tumor cell collection
- Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine
- Patients need not be in complete remission to receive study vaccine
- Patients may have received an allogeneic hematopoetic stem cell transplant in the past
- No chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment or within 3 weeks of vaccination
- Adequate hepatic function as defined by: Bilirubin < 2x normal; AST < 3x normal; ALT < 6x normal
- Adequate renal function defined by: Creatinine < 2x normal
- <1 year since tumor cell collection
Exclusion Criteria
- Concurrent treatment as part of another therapeutic research protocol
- Pregnancy or nursing mothers
- Clinically significant pulmonary or cardiac disease
- Clinically significant autoimmune disease
- Documented infection that is active and/or not responding to therapy
- Evidence of HIV infection or known positive HIV serology
- Lansky performance scale (if <18yo) <60%, Karnofsky performance scale (if >18yo) >60%
- Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy.
********************************************NOTE***************************************************
It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may include allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill eligibility criteria for vaccination in the future (i.e.
should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.***
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: CD40 Cell Vaccination
Patients will undergo tumor cell collection followed by vaccine preparation and then vaccination.
Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin (KLH), and then irradiated to produce the vaccine.
Patients receive either 1 x 10^7 or 1 x 10^8 CD40 cells/vaccination depending on the number of tumor cells obtained.
Vaccinations are administered every two weeks as outpatient therapy.
Evaluable patients receive the course of at least 4 vaccinations at weeks 0, 2, 4, 6.
Patients may continue receiving vaccinations every 2 weeks if chemotherapy is not required for symptomatic disease.
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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Rate Of Successful Vaccine Preparation
Tijdsspanne: 6 weeks
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Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10^8 cells) can be generated.
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6 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: W. Nicholas Haining, BM, BCh, Dana-Farber Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
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
- Leukemie
- Voorlopercel lymfoblastische leukemie-lymfoom
- Leukemie, Lymfoïde
- Fysiologische effecten van medicijnen
- Immunologische factoren
- Vaccins
Andere studie-ID-nummers
- 00-053
- P30CA006516 (Subsidie/contract van de Amerikaanse NIH)
- P01CA068484 (Subsidie/contract van de Amerikaanse NIH)
- DFCI-00053
- NCI-H01-0074
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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 CD 40
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Michael Rapoff, Ph.D.National Institute of Neurological Disorders and Stroke (NINDS)Voltooid
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Medical College of WisconsinChildren's Hospital of PhiladelphiaVoltooidKwaadaardige ziekten (dwz leukemie, MDS, lymfoom) | Niet-kwaadaardige ziekten (dwz beenmergfalensyndromen)Verenigde Staten
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National Heart, Lung, and Blood Institute (NHLBI)VoltooidHart-en vaatziekteVerenigde Staten
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Mashhad University of Medical SciencesBeëindigdInteractief op cd gebaseerd onderwijs
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Nile TherapeuticsVoltooidAcuut gedecompenseerd hartfalenVerenigde Staten, Duitsland, Israël
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Brooke Army Medical CenterOnbekend
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Shanghai Changzheng HospitalNog niet aan het wervenGeavanceerd hepatocellulair carcinoom
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Heidelberg UniversityJohannes Gutenberg University Mainz; Heidelberg University, Psychotherapy Research... en andere medewerkersVoltooidGedragsstoornisDuitsland
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Phramongkutklao College of Medicine and HospitalVoltooid
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Nile TherapeuticsVoltooid