临床试验/NCT00848016

NCT00848016已完成2 期

A Phase II Study of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients With Advanced Adrenocortical Carcinoma (ACC)

National Cancer Institute (NCI)2 个研究点分布在 1 个国家目标入组 29 人开始时间: 2009年2月最近更新: 2014年5月7日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 29
试验地点: 2
主要终点: The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria

研究概览研究设计入排标准研究组 & 干预措施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

This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

详细描述

PRIMARY OBJECTIVE:

I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid.

SECONDARY OBJECTIVES::

I. To evaluate the safety of this drug in these patients. II. To determine the progression-free and overall survival of these patients.

OUTLINE: This is a multicenter 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

•Histologically or cytologically confirmed adrenocortical carcinoma
•Recurrent, metastatic, or primary unresectable disease
•Measurable disease, defined as ≥ 1 lesion accurately measured in ≥ 1 dimension as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
•No adrenocortical tumors that, in the Principal Investigator's opinion, are potentially resectable by surgical excision alone
•No symptomatic or progressive brain metastases
•Patients with treated brain metastases ≥ 6 months prior to study who are clinically and radiographically stable or improved and are off steroids are eligible
•Must undergo an MRI of the brain or CT scan of the head with contrast ≤ 4 weeks prior to study
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
•Life expectancy ≥ 12 weeks
•White blood cell count (WBC) ≥ 3,000/mm3
•Absolute neutrophil count (ANC) ≥ 1,500/mm3
•Platelet count ≥ 100,000/mm3
•Total bilirubin < 1.5 mg/dL
•Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
•Serum creatinine ≤ 1.7 mg/dL or creatinine clearance ≥ 40 mL/min
•Able to take oral medications on a regular basis
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception prior to, during, and for ≥ 1 month after completion of study treatment
•No HIV positivity
•No uncontrolled intercurrent illness including, but not limited to, any of the following:
•Ongoing or active infection
•Symptomatic congestive heart failure
•Unstable angina pectoris
•Cardiac arrhythmia
•Psychiatric illness or social situation that would limit compliance with study requirements
•No condition or disease that significantly affects gastrointestinal (GI) function or impairs the ability to swallow and retain oral medications including, but not limited to, any of the following:
•GI tract disease or a requirement for IV alimentation
•Prior resection of the stomach or small bowel or surgical procedures affecting absorption
•Active peptic ulcer disease
•Malabsorption syndrome
•Ulcerative colitis
•Inflammatory bowel disease
•Partial or complete small bowel obstruction
•No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ cervical cancer
•No symptomatic hypercalcemia > grade 2
•No history of allergic reactions attributed to compounds of similar chemical or biological composition to R-(-)-gossypol acetic acid
•Fully recovered from prior surgical procedures and recovered to ≤ grade 1 from adverse events due to previous treatments
•No prior racemic gossypol or R-(-)-gossypol acetic acid
•More than 4 weeks since prior chemotherapy, biologic therapy, major surgery, or radiotherapy (≥ 6 weeks for carmustine or mitomycin C)
•Prior and concurrent mitotane and ketoconazole allowed for patients with hormonal excess
•More than 4 weeks since prior and no concurrent treatment with another investigational agent
•No concurrent prophylactic use of hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-11) during the first course of study treatment
•Not requiring routine use of platelet transfusions to maintain ANC or platelet count above required thresholds

排除标准

•No concurrent combination antiretroviral therapy for HIV-positive patients

研究组 & 干预措施

Treatment (R-(-)-gossypol acetic acid)

Experimental

Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: R-(-)-gossypol acetic acid (Drug)

结局指标

主要结局

The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria

时间窗: Up to 2 years

In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.

次要结局

Progression-free Survival(From registration to progression or death, whichever occurs first, up to 2 years.)
Overall Survival(From registration to date of last follow-up or death due to any cause, assessed up to 2 years)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (2)

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