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Идёт набор NCT01898039

Modified Vaccine for High Risk or Low Residual Melanoma Patients

Фаза I / Фаза II С лечением Malignant Melanoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: A2/4-1BBL melanoma vaccine, DNP sensititzation, Cyclophosphamide.
Кому может быть актуально
Состояния в реестре: Malignant Melanoma. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Израиль
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I/II Study.

Обзор

This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.

Вмешательства

  • Биопрепарат A2/4-1BBL melanoma vaccine
    On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.
  • Процедура DNP sensititzation
    Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site. On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.
  • Препарат Cyclophosphamide
    On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.

Первичные конечные точки

  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: Day 1]
  • monitoring anti-tumor immune response [Срок оценки: Day 0]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: Day 28]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: Day 56]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: month 3]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: month 4]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: month 5]
  • grade 2-4 adverse events according to CTCEA criteria [Срок оценки: month 6]
  • monitoring anti-tumor immune response [Срок оценки: Day 28]
  • monitoring anti-tumor immune response [Срок оценки: Day 56]
Вторичные конечные точки (1)
  • overall survival and disease free survival [Срок оценки: D1, Mo6, Mo10, Mo14, Mo18, Mo20, Mo24 and every 4 months till year 5]

Критерии участия

Критерии включения

  • Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
  • Cutaneous malignant melanoma AJCC stage IIb (>4 mm) or IIc (ulcerated melanoma >4mm).
  • Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.
  • Metastatic melanoma AJCC stage IV, completely resected.
  • Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
  • Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
  • Melanoma can be of either mutant or wild-type B-RAF.
  • Karnofsky performance status > 80 (Normal activity with effort).
  • No active cardio-respiratory disease.
  • Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >3000.
  • Informed consent of the patient.

Критерии исключения

  • Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
  • Active brain metastases requiring corticosteroids.
  • Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
  • Active serious infection.
  • Allergy to penicillin.
  • Patient's will to withdraw from the study at any stage.
  • HIV and chronic hepatitis B and C carrier

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Израиль · 1 центр
  • Sharett Institute of Oncology, Hadassah Medical Organization — Jerusalem

Идентификаторы

NCT: NCT01898039 · 0419-12-HMO-CTIL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗