Chemotherapy For Patients With Advanced Solid Tumors Or Non-Hodgkin's Lymphoma

Study Overview

Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

The purposes of this study are to determine: * the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle * the side effects of AQ4N when given on the above schedule * how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N * if AQ4N helps treat cancer

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.

Solid Malignancies
Non-Hodgkin's Lymphoma

DRUG: AQ4N

021-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-09-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2006-10-31
First Submitted that Met QC Criteria 2004-09-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2006-11-02
First Posted (ESTIMATED) 2004-09-06	Results First Posted N/A	Last Verified 2005-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record