NCT01247623已完成1 期
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Oslo University Hospital2 个研究点 分布在 1 个国家开始时间: 2005年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events).
Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses.
Secondary: Evaluation of objective tumour response
The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of malignant melanoma.
- •Previously untreated and non-resectable disease
- •Measurable or evaluable tumour.
- •Age ≥ 18 and ≤ 75 years.
- •Performance status ECOG-WHO 0, 1 and 2 (Appendix III)
- •Written informed consent (Appendix II)
- •Adequate bone marrow liver, heart and renal function:
- •WBC count >3.0 x 109/L and platelets count >100 x 109/L.
- •ASAT, ALAT <2 x upper normal laboratory value.
- •Serum creatinine <2 x upper normal laboratory value.
排除标准
- •Previous treatment with chemotherapy.
- •Clinical signs of brain metastases.
- •Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease.
- •Severe active infections such as HIV or hepatitis B or Hepatitis C.
- •Medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids).
- •Pregnancy, breast-feeding or absence of adequate contraception for fertile patients.
- •Simultaneously participation in other clinical studies.
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Peptide Vaccinations Plus GM-CT-01 in MelanomaMetastatic MelanomaNCT01723813Cliniques universitaires Saint-Luc- Université Catholique de Louvain6
已完成
1 期
A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast CancerBreast NeoplasmsNCT01265927Indiana University10
尚未招募
1 期
Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia PatientsAcute Myeloid Leukemia, AdultNCT06252584University Hospital Tuebingen20
已完成
1 期
Safety and Immunogenicity of Personalized Genomic Vaccine to Treat MalignanciesSolid TumorsNCT02721043Nina Bhardwaj13
已完成
1 期
A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian CancerFallopian TubePrimary Peritoneal CancerRecurrent Ovarian CancerOvarian CancerNCT02737787Memorial Sloan Kettering Cancer Center11