NCT00253474已完成1 期
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
研究概览
简要总结
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)
- Determine the toxicity profile of this drug in these patients.
Secondary
- Obtain, preliminary, information about the efficacy of this drug in these patients.
- Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
- Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of plexiform neurofibroma which is progressive, symptomatic, or life threatening and for which there is no other standard medical management or surgical option
- •Histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings provided the following are true:
- •No clinical observation or scan suggestive of malignant transformation
- •Meets ≥ 1 of the following diagnostic criteria for neurofibroma type 1 (NF1):
- •Six or more cafe-au-lait spots (> 0.5 cm in prepubertal patients or > 1.5 cm in post pubertal patients)
- •Freckling in axilla or groin
- •Optic glioma
- •Two or more Lisch nodules
- •A distinctive bony lesion (e.g., dysplasia of the sphenoid bone, dysplasia, or thinning of long bone cortex)
- •A first degree relative with NF1
- •No history of malignant peripheral nerve sheath tumor
- •No active visual pathway glioma
- •No active brain tumor or brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 12 months
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Hemoglobin > 10 g/dL
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 mg/dL
- •SGPT ≤ 2 times upper limit of normal
- •No significant hepatic dysfunction
- •Creatinine based on age as follows:
- •≤ 0.8 mg/dL (for patients age 5 years and under)
- •≤ 1.0 mg/dL (for patients age 6 to 10 years)
- •≤ 1.2 mg/dL (for patients age 11 to 15 years)
- •≤ 1.5 mg/dL (for patients age 16 to 21 years) OR
- •Creatinine clearance ≥ 70 mL/min
- •Cardiovascular
- •No significant cardiac dysfunction
- •No severe cardiovascular disease
- •No cardiac arrhythmia requiring chronic treatment
- •No congestive heart failure
- •No symptomatic ischemic heart disease
- •No significant pulmonary dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No serious infection
- •No other significant unrelated systemic illness
- •No significant organ dysfunction
- •No other malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No history of severe psychiatric condition or psychiatric disorder requiring hospitalization
- •No history of suicidal ideation or attempt
- •No thyroid dysfunction unresponsive to therapy
- •No uncontrolled diabetes mellitus
- •No history of HIV positivity
- 另有 15 项未显示
排除标准
- 未提供
研究者
研究点 (4)
Loading locations...
相似试验
终止
1 期
PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube CancerFallopian Tube CancerPeritoneal Cavity CancerOvarian CancerNCT00085384M.D. Anderson Cancer Center30
终止
不适用
Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCLLymphomaNCT00724061Northwestern University7
终止
1 期
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney CancerKidney CancerNCT00589550Thomas Olencki1
已完成
2 期
Interferon Alfa in Treating Children With HIV-Related CancerUnspecified Childhood Solid Tumor, Protocol SpecificLymphomaLeukemiaNCT00002621Children's Oncology Group8
终止
2 期
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00090870Medical University of South Carolina10