- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00262834
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
PRIMARY OBJECTIVE:
I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer.
OULINE: This is a multicenter, pilot study.
Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.
After completion of study treatment, patients are followed for 30 days.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
-
-
Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- No prior or concurrent hormonal therapy for breast cancer
- Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer
- ECOG 0-2 OR Karnofsky 60-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- PT ≤ 14 seconds
- Creatinine normal
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled intercurrent illness
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat
- At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
- Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
- No concurrent birth control pills
- No prior radiotherapy to the ipsilateral breast
- No prior or concurrent radiotherapy for breast cancer
- No prior or concurrent novel therapy for breast cancer
- At least 14 days since prior valproic acid or another histone deacetylase inhibitor
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent therapy for this cancer
- WBC ≥ 3,000/mm^3
Exclusion criteria:
- Patients must not be recieving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.
- Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.
- Women who are pregnant.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Arm I
Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
|
Given orally, conventional surgery to follow.
Другие имена:
Undergo conventional surgery
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Number of Participants With Adverse Events
Временное ограничение: After 3 days of vorinostat
|
Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery.
17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.
|
After 3 days of vorinostat
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Change in Tissue Proliferation After 3 Days of Treatment
Временное ограничение: After 3 days of vorinostat
|
Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups.
Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells.
A staining process can measure the percentage of tumor cells that are positive for Ki-67.
The more positive cells there are, the more quickly they are dividing and forming new cells.
|
After 3 days of vorinostat
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Change in Tissue Apoptosis After 3 Days of Treatment
Временное ограничение: Baseline and after 3 day of vorinostat
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Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups.
Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).
|
Baseline and after 3 day of vorinostat
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in Tissue Histone Acetylation After 3 Days of Treatment
Временное ограничение: Baseline and after 3 day of Vorinostat
|
To evaluate change from baseline in tissue histone acetylation in patients with primary breast cancer who received three days of Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.
This is measured by Cumulative Methylation Index, which is reported as the sum of all %M for all genes.
%M= (methylated copies divided by methylated + unmethylated copies) x 100.
|
Baseline and after 3 day of Vorinostat
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Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment
Временное ограничение: Baseline and after 3 day of Vorinostat
|
To evaluate baseline and change in histone acetylation in polymononuclear cells in patients with primary breast cancer who received three days of SAHA 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.
|
Baseline and after 3 day of Vorinostat
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Vered Stearns, Johns Hopkins University/Sidney Kimmel Cancer Center
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NCI-2009-00098 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- P30CA006973 (Грант/контракт NIH США)
- U01CA070095 (Грант/контракт NIH США)
- 6914 (Другой идентификатор: CTEP)
- CDR0000445404 (Другой идентификатор: Clinical Data Repository (CT.gov))
- SKCCC J0504 (Другой идентификатор: Johns Hopkins University/Sidney Kimmel Cancer Center)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .