Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
21 февраля 2017 г. обновлено: University of Pennsylvania
Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production.
All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells.
All patients will receive mature DC for each dose of vaccine.
For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides.
All patients will receive booster doses with mature DC.
The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses.
Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Restaging is performed after three and six vaccine doses.
Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
Тип исследования
Интервенционный
Регистрация (Действительный)
17
Фаза
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Missouri
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St. Louis, Missouri, Соединенные Штаты, 63110
- Washington University School of Medicine
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
- Age ≥ 18 years
- Life expectancy ≥ 4 months
- ECOG performance status 0-2
- At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
Required initial laboratory values (submitted within 14 days prior to registration):
- WBC >3,000/mm3
- Hg ≥ 9.0 gm/dl
- Platelets >75,000/mm3
- Serum Bilirubin < 2.0 mg/dl
- Serum Creatinine < 2.0 mg/dl
- Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
Exclusion Criteria:
- Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
- Active untreated CNS metastasis
- Active infection
- Prior malignancy (except non-melanoma skin cancer) within 3 years
- Pregnant or nursing
- Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
- Inability to provide adequate informed consent
- Known allergy to eggs
- Prior history or uveitis or autoimmune inflammatory eye disease.
- Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Dendritic Cell Vaccine (First Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
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Другие имена:
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Экспериментальный: Dendritic Cell Vaccine (Second Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
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Другие имена:
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Экспериментальный: Dendritic Cell Vaccine (Third Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.
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Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.
Временное ограничение: Through completion of treatment
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Through completion of treatment
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Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events
Временное ограничение: 30 days after end of treatment
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The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
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30 days after end of treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time to progression
Временное ограничение: Through completion of treatment or until progressive disease
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Through completion of treatment or until progressive disease
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Regulatory T cell depletion after cyclophosphamide administration.
Временное ограничение: Day -3 (72 hours prior to vaccine dose 1)
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Regulatory T cells (Treg) are defined as CD4+CD25+foxP3+ (triple positive) cells.
At the indicated time points, the percentage of Treg cells is determined by 3 color flow cytometry.
The depletion of Treg is defined as follows [Treg baseline - Treg nadir/ Treg baseline x 100= % depletion].
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Day -3 (72 hours prior to vaccine dose 1)
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Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.
Временное ограничение: Day 0 (prior to vaccine dose 1)
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Day 0 (prior to vaccine dose 1)
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Clinical response rate using RECIST criteria
Временное ограничение: After third vaccine, sixth vaccine, and then every 8 weeks
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After third vaccine, sixth vaccine, and then every 8 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Gerald P. Linette, M.D., Ph.D., Abramson Cancer Center of the University of Pennsylvania
Публикации и полезные ссылки
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 августа 2008 г.
Первичное завершение (Действительный)
1 июня 2016 г.
Завершение исследования (Действительный)
1 июня 2016 г.
Даты регистрации исследования
Первый отправленный
19 мая 2008 г.
Впервые представлено, что соответствует критериям контроля качества
19 мая 2008 г.
Первый опубликованный (Оценивать)
23 мая 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
23 февраля 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 февраля 2017 г.
Последняя проверка
1 февраля 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по гистологическому типу
- Новообразования
- Нейроэктодермальные опухоли
- Новообразования, зародышевые клетки и эмбриональные
- Новообразования, нервная ткань
- Нейроэндокринные опухоли
- Невусы и меланомы
- Меланома
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Противоревматические агенты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Противоопухолевые агенты, алкилирующие
- Алкилирующие агенты
- Миелоаблативные агонисты
- Циклофосфамид
Другие идентификационные номера исследования
- 07-0652 / 826850
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