临床试验/NCT00714181

NCT00714181已完成1 期

A Phase I Study of Hydroxychloroquine in Combination With Temozolomide in Patients With Advanced Solid Tumors

Abramson Cancer Center at Penn Medicine2 个研究点分布在 1 个国家目标入组 38 人开始时间: 2008年6月最近更新: 2016年2月18日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Abramson Cancer Center at Penn Medicine
入组人数: 38
试验地点: 2
主要终点: Maximum tolerated dose of hydroxychloroquine

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine when given together with temozolomide in treating patients with metastatic or unresectable solid tumors.

详细描述

OBJECTIVES:

Primary

To determine the maximum tolerated dose (MTD) of hydroxychloroquine (HCQ) when administered in combination with temozolomide (TMZ) in patients with metastatic or unresectable solid tumors.

Secondary

To determine the toxicity and toxicity rate of HCQ when administered at the MTD in combination with TMZ in these patients.

研究设计

研究类型: Interventional
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 120 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Maximum tolerated dose of hydroxychloroquine

次要结局

Pharmacodynamic and pharmacokinetic correlative endpoints
Toxicity rates

研究者

发起方

Abramson Cancer Center at Penn Medicine

申办方类型

Other

责任方

Sponsor

研究点 (2)

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