- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00059995
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
Обзор исследования
Подробное описание
OBJECTIVES:
- Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.
- Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Тип исследования
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mayo Clinic Cancer Center
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New York
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New York, New York, Соединенные Штаты, 10021
- Memorial Sloan-Kettering Cancer Center
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell or T-cell lymphoma
- Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
- No HIV-associated lymphoma
CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
- At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
Must meet one of the following criteria for relapsed/refractory disease:
Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
- Relapsed disease must be within the prior irradiated field
Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
- Disease progression must be within the prior irradiated field
- Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
PATIENT CHARACTERISTICS:
Age
- Over 12
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 1,500/mm^3*
- Neutrophil count at least 1,000/mm^3*
- Platelet count at least 75,000/mm^3*
- Hemoglobin at least 8.0 g/dL* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Hepatic
- AST no greater than 2 times upper limit of normal (ULN)*
- Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)*
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Renal
- Creatinine no greater than 2 times ULN* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 9 months after study participation
- HIV negative
- No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No active significant infection
No apparent opportunistic infection, as indicated by any of the following:
- Purified protein derivative recently determined to be positive
- Infectious infiltrate by chest x-ray
- Recent changes in fever/chill patterns
- New, unexplained neurological symptoms
- No underlying medical condition that would preclude receiving study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior anti-CD30 antibody therapy
- No other concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- No concurrent systemic steroidal therapy (excluding physiologic doses)
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Маскировка: Нет (открытая этикетка)
Соавторы и исследователи
Соавторы
Следователи
- Учебный стул: Steven M. Horwitz, MD, Memorial Sloan Kettering Cancer Center
Публикации и полезные ссылки
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MDX-060-01
- MSKCC-02121
- CDR0000298995 (Идентификатор реестра: PDQ (Physician Data Query))
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