A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
Data Collection
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments. AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth. All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred * Age \> 18 years * Adequate hematologic (blood), kidney and liver function * Negative pregnancy test (females of childbearing potential only) * Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment. Exclusion Criteria: * Any chemotherapy or radiation within the past 4 weeks * Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible) * Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat * Inadequate cardiac function * Prior investigational therapy within the past 28 days * Pregnant or breast feeding women
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Cancer Therapy & Research Center / Institute for Drug Development
San Antonio, United States