Clinical trial NCT00090727: Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official title: A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Malignancies
Non-Hodgkin's Lymphoma
Keywords: diffuse
follicular
chronic lymphocytic leukemia
colorectal cancer
pancreatic cancer
acute myelogenous leukemia
head and neck cancer
breast cancer
prostate cancer
ovarian cancer
bladder cancer
hypoxia
refractory
metastatic
Lead sponsor: Novacea
Sponsor class: INDUSTRY
First posted: 2004-09-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Weiler Hospital of Albert Einstein College of Medicine
state: New York
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center / Institute for Drug Development
state: Texas
Study officials:
References: