NCT00045136已完成1 期
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
Poniard Pharmaceuticals10 个研究点 分布在 1 个国家开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
详细描述
OBJECTIVES:
- Determine the radiation absorbed dose of holmium Ho 166 DOTMP to the kidney in patients with multiple myeloma, based on whole body gamma camera image data for comparison with that obtained using an ICRP mathematical model.
- Determine the average marrow dose of this drug in these patients using gamma camera whole body counts in patients receiving this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Compare marrow dose estimates determined from gamma camera whole-body counts and thyroid uptake probe counts in patients receiving this drug.
- Evaluate intra-patient variability of the uptake of this drug in the bone with repeat tests.
- Determine whether the biodistribution and dosimetry is influenced by administering this drug as a bolus compared to a 15-minute infusion in these patients.
- Compare the reduction in dose rate from the 15-minute infusion vs the bolus injection of this drug to estimate the effect on kidney exposure in these patients.
- Determine the renal transit time for each patient after bolus injection of this drug and assess whether this information improves the dose estimate to kidney with the mathematical model.
- Determine whether there is correlation of renal transit time from technetium Tc 99m-diethylenetriaminepentaacetic acid (DTPA) with holmium Ho 166 DOTMP.
- Determine the adverse events in patients receiving this drug.
- Determine the efficacy of a targeted therapy dose of holmium Ho 166 DOTMP with melphalan followed by autologous peripheral blood stem cell transplantation in these patients.
OUTLINE: This is a multicenter study. Patients are entered into one of two cohorts.
- Cohort A: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on day 1 and then IV bolus on day 8.
- Cohort B: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on days 1 and 8.
After each diagnostic dose, patients in both cohorts also undergo gamma camera imaging of the whole body on days 1 and 8.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma (MM)
- •Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the criteria for diagnosis of MM
- •No non-secretory MM
- •No symptomatic MGUS, smoldering MM, or indolent MM
- •No solitary bone or extramedullary plasmacytoma
- •No immunoglobulin M myeloma
- •Prior induction therapy for myeloma required
- •Responding, stable, or progressive disease after induction therapy, or relapsed disease
- •Candidate for autologous hematopoietic stem cell transplantation
- •Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures
- •Availability of at least 2,000,000 CD34+ cells/kg
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 2 mg/dL
- •SGPT no greater than 2 times upper limit of normal
- •No clinical evidence of amyloidosis of the liver
- •Creatinine no greater than 2.0 mg/dL
- •Creatinine clearance at least 45 mL/min
- •Renal ultrasound normal
- •No clinical evidence of amyloidosis of the kidney
- •No urinary obstruction in the renal pelvis, ureter, or bladder outlet by ultrasound
- •Cardiovascular
- •Ejection fraction at least 50% with no evidence of amyloidosis by echocardiogram
- •No clinical evidence of amyloidosis of the heart
- •No uncontrolled arrhythmia
- •No symptomatic cardiac disease
- •FEV1, FVC, and DLCO at least 60%
- •No symptomatic pulmonary disease
- •No clinical evidence of amyloidosis of the lungs
- •No known allergy to vitamin C or bisphosphonates
- •No known hypersensitivity to technetium Tc 99m phosphorus radiopharmaceuticals (e.g., technetium Tc 99m-methylene diphosphonate)
- •No concurrent illness that would severely limit life expectancy
- •No symptoms, physical findings, or radiographic evidence of cord compression
- •No clinical evidence of amyloidosis of the autonomic nervous system or gastrointestinal tract
- •No prior noncompliance in other studies
- •No other malignancy within the past 5 years except treated indolent skin cancers or carcinoma in situ of the cervix
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior stem cell or bone marrow transplantation
- •No concurrent maintenance therapy comprising interferon or thalidomide
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00016367M.D. Anderson Cancer Center22
已完成
不适用
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast CancerBreast CancerNCT00003730European Organisation for Research and Treatment of Cancer - EORTC80
已完成
3 期
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00012389Sanofi
Unknown
3 期
Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's LymphomaLymphomaNCT00003815Scotland and Newcastle Lymphoma Group
已完成
3 期
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic Breast CancerBreast CancerNCT00002870UNICANCER180