NCT00062244已完成1 期
Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 16
- 主要终点
- Maximum tolerated dose determined by the number of dose-limiting toxicity incidents graded according to CTC standard toxicity (Phase I)
研究概览
简要总结
This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) and recommended dosing for Genasense in patients with relapsed or refractory WM following prior chemotherapy. (Phase I) II. To determine the response rate to Genasense in patients with relapsed or refractory WM following prior chemotherapy.
III. To determine the safety of Genasense in patients with relapsed or refractory WM following prior chemotherapy.
IV. To describe possible clinical benefit from Genasense treatment of relapsed or refractory WM including duration of response, survival, erythropoietin use, improvement in hemoglobin > 11 g/dl, and Improvement in platelet count > 100,000/mm^3.
OUTLINE: This is a multicenter, dose-escalation study.
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
- •Diagnosis of Waldenstrom's macroglobulinemia (WM) confirmed by both of the following:
- •Bone marrow lymphoplasmacytosis with greater than 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy
- •Measurable disease, defined by quantitative IgM monoclonal protein greater than 1,000 mg/dL
- •Symptomatic relapsed or refractory disease requiring therapy, defined by at least 1 of the following:
- •Impaired bone marrow function due to disease infiltration as demonstrated by any of the following:
- •Hemoglobin less than 11 g/dL
- •Requires epoetin alfa therapy to maintain hemoglobin of at least 11 g/dL
- •Platelet count less than 100,000/mm^3
- •Symptomatic bulky lymphadenopathy
- •Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage) or serum viscosity level relative to water greater than 4
- •Received at least 1 prior chemotherapy regimen which included chlorambucil, cyclophosphamide, fludarabine, cladribine, or pentostatin
- •No secondary leukemia or history of antecedent hematologic disorder (e.g., myelodysplasia) prior to initial onset of WM
- •Performance status - ECOG 0-2
- •Not specified
- •See Disease Characteristics
- •Absolute neutrophil count at least 1,000/mm^3*
- •Platelet count at least 50,000/mm^3*
- •No bleeding disorder
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST less than 1.5 times ULN
- •Albumin at least 2.5 g/dL
- •PT no greater than 1.5 times ULN
- •INR no greater than 1.3
- •PTT no greater than 1.5 times ULN
- •No history of chronic hepatitis or cirrhosis
- •Creatinine no greater than 2 times ULN
- •No uncontrolled congestive heart failure
- •No active symptoms of coronary artery disease, including the following:
- •Uncontrolled arrhythmias
- •Recurrent chest pain despite prophylactic medication
- •No New York Heart Association class III or IV heart disease
- •No grade 2 or greater cardiovascular signs and symptoms within the past 4 weeks
- •HIV negative
- •Direct Coombs' test negative
- •No autoimmune thrombocytopenia
- •No uncontrolled serious infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Adequate venous access for 7-day continuous infusion of study drug
- •Intellectual, emotional, and physical ability to maintain an ambulatory infusion pump
- •No other cancer except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for at least 5 years
- •No known hypersensitivity to phosphorothioate-containing oligonucleotides
- •No uncontrolled seizure disorder
- •More than 21 days since prior immunotherapy for WM
- •More than 21 days since prior cytokine, biologic, or vaccine therapy for WM
- •More than 8 weeks since prior plasmapheresis or plasma exchange
- •No prior allogeneic stem cell transplantation
- •No concurrent plasmapheresis or plasma exchange
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose determined by the number of dose-limiting toxicity incidents graded according to CTC standard toxicity (Phase I)
时间窗: 21 days
Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.
次要结局
- Adverse events that are classified as either possibly, probably, or definitely related to study treatment (Phase II)(Up to 2 years)
- Proportion of overall confirmed responses (CR + PR) associated with G3139 (Phase II)(6 months)
- Time to progression(Time from registration to the time of progression, assessed up to 2 years)
- Overall survival(Time from registration to death due to any cause, assessed up to 2 years)
- Duration of response(From the documentation of response until the date of progression, assessed up to 2 years)
研究者
研究点 (16)
Loading locations...
相似试验
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
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
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
已完成
2 期
Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell CancerRecurrent Renal Cell CancerStage IV Renal Cell CancerNCT00059813National Cancer Institute (NCI)41
已完成
1 期
A Phase I Study of G3139 Subcutaneous in Solid TumorsTumorsNCT00543231Genta Incorporated8