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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

Conditions
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Solid Malignancies, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: AQ4N


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AQ4N|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, diffuse, follicular, chronic lymphocytic leukemia, colorectal cancer, pancreatic cancer, acute myelogenous leukemia, head and neck cancer, prostate cancer, ovarian cancer, bladder cancer, hypoxia, refractory, metastatic