NCT00059813已完成2 期
A Phase II Trial of G3139 (Genasense) Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)
研究概览
简要总结
Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of metastatic renal cancer to the combination of G3139 plus α-Interferon (α-IFN).
SECONDARY OBJECTIVES:
I. To further assess the clinical toxicity of this combination. II. To evaluate the impact of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor cells and lymphocytes.
III. To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, measurable metastatic renal cell cancer; if a nephrectomy was performed in the setting of metastatic disease, post-nephrectomy progression of metastases must be documented
- •Performance status 0-2 (SWOG), life expectancy > 3 months
- •Prior radiation must have been completed > 4 weeks before enrollment, with measurable disease outside of the radiation port
- •WBC > 3500/μl
- •Absolute neutrophil count > 1500/μl
- •Platelets > 100,000/μl
- •Transaminases < 2 x institutional upper limit of normal
- •Serum bilirubin < 1.5 x institutional upper limit of normal (if Gilbert's, up to 2 x upper limit)
- •Serum alkaline phosphatase < 2.5 x institutional upper limit of normal
- •Patients with hepatic metastases may have 50% higher levels of all the above-listed parameters
- •Serum creatinine < 1.5 x institutional upper limit of normal
- •Patients with active or recently-treated autoimmune disease are excluded, as are patients currently receiving or expected to require corticosteroid therapy
- •Prior malignancy is limited to adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, or any other malignancy for which the patient has been disease-free for at least 5 years
- •Because the effects of G3139 on the unborn fetus or newborn infant are unknown, pregnant or lactating women are excluded, and patients with reproductive potential must agree to use a medically-acceptable form of birth control
- •Patients must have fully recovered from the effects of any prior surgery or medical illness such as infection; those with psychosocial problems that might compromise safety or protocol compliance are excluded
- •Central venous access is required
- •Patients may have received up to two prior biological therapy regimens, excluding exposure to either of the therapy agents and patients may have had no more than one prior chemotherapy regimen; full recovery from all toxicities must have occurred; for high-dose IL-2, at least 8 weeks must have elapsed since prior treatment
- •Written, voluntary informed consent
- •Previous chemotherapy must have been completed at least 3 weeks before treatment under this protocol can be initiated
- •Patients with a history of brain metastases, or who are currently being treated, or have untreated brain metastases, are not eligible; Note: if patient received steroid therapy, at least three weeks must have elapsed prior to entry on this protocol
- •Patients must have normal baseline PT/PTT; Note: For those patients taking low dose coumadin (e.g., as prophylaxis for a venous access device) and INR of up to 1.5 is allowed
排除标准
- 未提供
结局指标
主要结局
Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)
时间窗: Start of the treatment until disease progression/recurrence, assessed up to 5 years
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
次要结局
- Overall survival(Time from first day of treatment to time of death due to any cause, assessed up to 5 years)
- Progression free survival(Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 5 years)
- Time to progression(Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 5 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Oblimersen and Imatinib Mesylate in Treating Patients With Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous LeukemiaRelapsing Chronic Myelogenous LeukemiaNCT00049192National Cancer Institute (NCI)43
终止
1 期
Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerMale Breast CancerNCT00063934National Cancer Institute (NCI)31
已完成
1 期
Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaNCT00086944National Cancer Institute (NCI)25
已完成
1 期
Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid TumorsCardiac ToxicityUnspecified Childhood Solid Tumor, Protocol SpecificNCT00039481National Cancer Institute (NCI)15
已完成
2 期
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaNodal Marginal Zone B-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaTesticular LymphomaWaldenström MacroglobulinemiaNCT00054639National Cancer Institute (NCI)48