- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01127594
Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion
A Multi-Center Phase I Dose Escalation Trial to Evaluate Safety and Tolerability of Intra-Arterial Temozolomide for Patients With Advanced Extremity Melanoma Using Normothermic Isolated Limb Infusion
Studieoversigt
Detaljeret beskrivelse
- The primary objective of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment and to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial.
- Population will include patients who have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease. Study activities include tumor tissue sampling, blood sampling, and subjects will undergo an Isolated Limb Infusion.
- To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI. Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI). A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment. ILI with melphalan has a complete response rate of approximately 35% in naïve patients and 20% in patients who have previously received melphalan based regional therapy.
To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Florida
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Tampa, Florida, Forenede Stater, 33612
- Moffitt Cancer Center
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- MD Anderson 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:
- Patient must have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease.
- Patient must be 18 years of age or older.
- Patient must have an ECOG status of 0-1.
- Patient must have histologically proven primary or recurrent extremity melanoma, stage IIIB, IIIC, or IV
- Patients with Stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed at the time of regional treatment.
- Patients with Stage IV disease must have had all distant disease resected at least 30 days prior to regional treatment.
- Disease to be treated by ILI must be distal to the planned site of tourniquet placement
- Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the RECIST criteria.
- Patient must have adequate bone marrow, liver and renal function
- Patient must have a palpable femoral/radial pulse in the affected extremity.
- Recovery from relevant toxicity prior to first study drug administration.
- Patients must have a life expectancy of > 6 months.
- Ability to read and understand English and the ability to complete paper +/- electronic survey assessments.
Exclusion Criteria:
- Cardiac disease: Congestive heart failure > class II NYHA.
- Known brain metastasis.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of administration of TMZ
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of administration of TMZ.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgery or significant traumatic injury within 30 days of ILI.
- Evidence or history of bleeding diathesis or coagulopathy.
- Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration.
- Patients with symptoms or signs of vascular insufficiency. Specifically, patients with any history of blood clots or lifestyle altering ischemic peripheral vascular disease will be excluded.
- History of allergic reactions and/or hypersensitivity to TMZ.
- Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance.
- Pregnant or nursing women are not eligible for this study. Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects. All female participants of child-bearing potential must have a negative serum pregnancy test within two weeks of patient registration. Please note: use of contraception, including surgical procedures such as vasectomy or tubal ligation DO NOT eliminate the need for administering pregnancy testing.
- Current treatment, or treatment in the previous 24 months, for another non-melanoma malignancy.
- Unable to return at the regular required intervals for reassessment, or study drug administration.
- Patients with known heparin induced thrombocytopenia.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Safety Profile of intra-arterial temozolomide and maximum tolerated dose of temozolomide
Tidsramme: 12 Weeks
|
To determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting (DLT) and non dose limiting toxicities associated with this treatment. To determine the maximum tolerated dose (MTD) for intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial. |
12 Weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To define tumor response in field in patients treated with temozolomide
Tidsramme: Until disease progression or death
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To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI at the MTD dose.
Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI).
A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment.
To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.
|
Until disease progression or death
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Douglas S Tyler, MD, Duke University
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
- Neoplasmer efter histologisk type
- Neoplasmer
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Melanom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre undersøgelses-id-numre
- Pro00020406
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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 Temozolomide
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Bradmer Pharmaceuticals Inc.Afsluttet
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Novartis PharmaceuticalsAfsluttetGlioblastomAustralien, Spanien, Canada, Forenede Stater
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Activartis BiotechAfsluttet
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University of SouthamptonBristol-Myers SquibbRekrutteringKræft i spiserøret | Adenocarcinom - GEJDet Forenede Kongerige
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Peking Union Medical College HospitalBeijing Tiantan Hospital; Tianjin Medical University General HospitalUkendtOndartede gliomerKina
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University of Colorado, DenverCancer League of ColoradoAfsluttetIkke småcellet lungekræft | CNS ProgressionForenede Stater
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Yong-Kil HongNational Cancer Center, Korea; Samsung Medical Center; Seoul St. Mary's Hospital og andre samarbejdspartnereAfsluttet
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Fox Chase Cancer CenterNational Cancer Institute (NCI)Afsluttet
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European Organisation for Research and Treatment...AfsluttetTumorer i hjernen og centralnervesystemetFrankrig, Danmark, Holland, Belgien, Tyskland, Sverige, Det Forenede Kongerige, Finland, Portugal, Østrig, Ungarn, Italien
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Haukeland University HospitalUniversity of Oslo; Oslo University Hospital; University Hospital of North... og andre samarbejdspartnereRekruttering