A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Toxicity graded using the NCI CTCAE version 3.0
研究概览
简要总结
This phase I/II trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oblimersen when given in combination with rituximab, ifosfamide, carboplatin, and etoposide in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
II. Determine the safety and toxicity of this regimen in these patients. III. Determine the complete and partial response rate in patients treated with this regimen.
SECONDARY OBJECTIVES:
I. Determine the duration of response, overall survival, and time to progression in patients treated with this regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma
- •Any 1 one of the following histological subtypes for phase I:
- •Grade 3 follicular center lymphoma
- •Diffuse large B-cell lymphoma
- •Transformed follicular lymphoma
- •Mantle cell lymphoma
- •Primary mediastinal B-cell lymphoma
- •Any 1 of the following histological subtypes for phase II:
- •Diffuse large B-cell lymphoma
- •Transformed follicular lymphoma
- •Primary mediastinal B-cell lymphoma
- •Measurable disease
- •At least 1 bidimensionally measurable lesion ≥ 10 mm in longest diameter by CT scan, MRI, x-ray, or clinical exam
- •Relapsed disease after 1, and only 1, prior anthracycline-based chemotherapy regimen
- •No known brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 3 months
- •Absolute neutrophil count ≥ 1,000/mm^3*
- •Platelet count ≥ 100,000/mm^3*
- •Bilirubin normal**
- •AST and ALT ≤ 2.5 times upper limit of normal
- •PT and PTT normal
- •Creatinine normal
- •Creatinine clearance ≥ 60 mL/min
- •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 history of allergic reactions attributed to compounds of similar chemical or biological composition to oblimersen or other study drugs
- •No currently active second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Must have completed any prior therapy for a second malignancy and is considered to be at < 30% risk of relapse
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •Prior rituximab allowed
- •No other concurrent immunotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No other concurrent chemotherapy
- •No concurrent hormonal therapy
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent therapeutic radiotherapy
- •At least 4 weeks since prior surgery
- •No prior oblimersen or other antisense oligonucleotide therapy
- •No other concurrent anticancer agents or therapies
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: oblimersen sodium (Biological)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: rituximab (Biological)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: ifosfamide (Drug)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: carboplatin (Drug)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: etoposide (Drug)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: filgrastim (Biological)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: pegfilgrastim (Biological)
Treatment (genase, combination chemotherapy)
See detailed description.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Toxicity graded using the NCI CTCAE version 3.0
时间窗: Up to 3 years
Complete and partial response rate according to the International Workshop Criteria
时间窗: Up to 3 years
次要结局
- Duration of response(From the time measurement criteria are met for CR/CRu/PR until the first date that PD is objectively documented, assessed up to 3 years)
- Overall survival(From the first day of therapy to the date of death, assessed up to 3 years)
- Time to progression(From the first day of treatment until the date PD or death is first reported, assessed up to 3 years)