- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00680589
Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse TYRP2 in patients with melanoma. DNA is a material that contains the information needed to produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps to produce their black color. The DNA used in this study is the gene for mouse TYRP2.
The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is then made from bacteria that is inactive.
We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA. We will also follow the patients closely to see if there are any side effects. Mouse TYRP2 DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T cells) that recognize melanoma cells. Antibodies are substances produced by your immune system to defend your body against bacteria and viruses. T cells are a type of white blood cell that can also fight infections. The small differences between mouse and human TYRP2 may allow your immune system to make the antibodies and T cells against melanoma. There is no evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A*0201 positive.
- Patients must have a Karnofsky performance status of at least 80.
- Patients must be free of detectable brain metastases.
- Patients must have adequate organ and marrow function as defined below:
- WBC ≥ than or = to 3,000/μL
- Absolute neutrophil count ≥ than or = to 1,500/μL
- Platelets ≥ than or = to 100,000/μL
- Total bilirubin ≤ than or = to 1.5X upper normal institutional limits
- LDH ≤ than or = to 2 X institutional upper limit of normal
- Albumin ≥ than or = to 3.5 mg/dl
- Creatinine ≤ than or = to 2.0 mg/dl
- Hemoglobin ≥ than or = to 10 Gm/dl
- Liver AST, ALT ≤ than or = to 2.5 x ULN
- Patients must have no known HIV positivity
- Pediatric patients are eligible if weight is > 25 kg and parent/guardian completes informed assent process.
- Patients must understand and sign an informed consent and have specifically declined all standard or approved therapies for which they would be considered eligible. Parent or legal guardians of patients who are minors will sign the informed consent form.
- As part of the consent process, patients must agree to use contraception while on study.
Exclusion Criteria:
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. For nitrosoureas, at last six weeks must have elapsed.
- Patients with Grade I fever, active infection, or antibiotics within 72 hours prior to study.
- Patients who have previously been immunized with any class of vaccine containing TYRP2, including whole cell, shed antigen or cell lysate vaccine.
- Patients with a history of collagen vascular, rheumatological, or other autoimmune disorders.
- Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- Patients who have preexisting retinal or choroidal eye disease.
- Patients with serious underlying medical conditions that could be exacerbated by participation, active infections requiring antimicrobial drugs or active bleeding.
- Pregnant women or women who are nursing are not eligible. Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative βHCG within 2 weeks of immunization) nor be nursing during treatment.
- Patients receiving other investigational agents.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
Injection of mouse TYRP2 DNA in patients with highrisk melanoma.
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Cohorts of three patients will receive injections with mouse TYRP2 DNA delivered intramuscularly at four different dose levels (500, 2000, 4000 or 8000 μg) every three weeks for six injections.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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To evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose.
Tidsramme: conclusion of study
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conclusion of study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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A secondary endpoint is to observe the patients for evidence of any antitumor response generated after immunizations.
Tidsramme: conclusion of study
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conclusion of study
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-052
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Kliniske forsøg med Melanom
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbAktiv, ikke rekrutterendeMetastatisk uveal melanom | Metastatisk malign neoplasma i leveren | Stage IV Uveal Melanoma AJCC v7Forenede Stater
Kliniske forsøg med injection of mouse TYRP2 DNA
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Kirby InstituteTrukket tilbage
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Istanbul University - Cerrahpasa (IUC)Scientific Research Project Coordination Unit of Istanbul University-CerrahpasaAktiv, ikke rekrutterendeHjerte-kar-sygdomme | Hot blinker | Søvn | Overgangsalderen | Epigenetik | DNA-methyleringKalkun
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University of Kansas Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...Afsluttet
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Antonio Giordano, MDCardiff OncologyRekrutteringBrystkræft | Metastatisk brystkræft | Inflammatorisk brystkræft | Invasiv brystkræft | Lokalt avanceret brystkræft | Brystkarcinom, der ikke kan opløses | HER2-negativ brystkræft | Tredobbelt negativ brystkræft (TNBC) | Hormonreceptor negativt brystkarcinom | Hormonreceptor/vækstfaktorreceptornegativ brystkræftForenede Stater