- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01970527
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab.
SECONDARY OBJECTIVES:
I. To determine late toxicity and immune pharmacodynamic changes after SBRT followed by ipilimumab.
OUTLINE:
Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab intravenously (IV) every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutch/University of Washington Cancer Consortium
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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:
- Histologically confirmed diagnosis of melanoma
- Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria
- Presence of an index lesion between 1 and 5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Signed informed consent document
- Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
- Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)
Exclusion Criteria:
- Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
- Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
- Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active
- Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study
- Prior radiation therapy (RT) that precludes the delivery of SBRT
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: Treatment (stereotactic body radiotherapy, ipilimumab)
Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13.
Patients then receive ipilimumab IV every 3 weeks.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
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Korrelative undersøgelser
Korrelative undersøgelser
Givet IV
Andre navne:
Gennemgå SBRT
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Immune-related Clinical Response, Defined as Proportion of Patients Treated at the Maximum-tolerated Dose (MTD) Who Achieve Either a Complete or Partial Immune-related Response
Tidsramme: Up to 60 days after last ipilimumab injection
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Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1.
The number of immune-related responses will be tabled by stratum and SBRT fraction dose level.
At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients.
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Up to 60 days after last ipilimumab injection
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Immune-related Progression-free Survival (irPFS)
Tidsramme: Time from first day of radiotherapy to first documented immune-related progressive disease, death due to any cause or last patient contact alive and progression-free, assessed at 6 months
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irPFS will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.. For some patients no scans were available for irRECIST reads, in which case change of management was determined to be the point of progression. |
Time from first day of radiotherapy to first documented immune-related progressive disease, death due to any cause or last patient contact alive and progression-free, assessed at 6 months
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Late Toxicities, Graded According to the Radiation Therapy Oncology Group/European Organization for Research, the Treatment of Cancer Late Morbidity Scoring System, and the Common Terminology Criteria for Adverse Events Version 4.0
Tidsramme: Up to 3 years
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Defined generally as an adverse event associated with the treatment which occurs beyond 30 days after last injection (i.e., adverse events which are observed months after treatment are most likely associated with SBRT).
All dose-limiting toxicities and late toxicities will be graded and tabled by lesion site stratum and SBRT fraction dose level.
Toxicity attribution to either SBRT or ipilimumab will be described if possible.
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Up to 3 years
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Overall Survival
Tidsramme: Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months
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Will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.
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Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
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, immunologiske
- Immune Checkpoint-hæmmere
- Ipilimumab
Andre undersøgelses-id-numre
- 9031 (CTEP)
- P30CA015704 (U.S. NIH-bevilling/kontrakt)
- NCI-2013-01757 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Stadie IV Hudmelanom
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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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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)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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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)Trukket tilbageMetastatisk melanom | Fase III kutan melanom AJCC v7 | Fase IV kutan melanom AJCC v6 og v7 | Avanceret malignt fast neoplasma | Metastatisk malignt fast neoplasma | Fase IIIC kutan melanom AJCC v7 | Østrogenreceptor negativ | HER2/Neu negativ | Progesteronreceptor negativ | Triple-negativt brystkarcinom | Uoprettelig... og andre forhold
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk 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
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