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

Sponsored by:	Novacea
Information provided by:	Novacea
ClinicalTrials.gov Identifier:	NCT00090727

Purpose

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

Condition	Intervention	Phase
Solid Malignancies Non-Hodgkin's Lymphoma	Drug: AQ4N	Phase I

Genetics Home Reference related topics: bladder cancer breast cancer

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

Further study details as provided by Novacea:

Estimated Enrollment:	45
Study Start Date:	August 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090727

Locations

United States, New York
Weiler Hospital of Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Texas
Cancer Therapy & Research Center / Institute for Drug Development
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Novacea

More Information

Novacea website This link exits the ClinicalTrials.gov site

Study ID Numbers:	021-001
Study First Received:	September 2, 2004
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00090727
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novacea:

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

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Ovarian cancer
Leukemia, Lymphoid
Immunoproliferative Disorders
Ovarian Neoplasms
Leukemia, B-cell, chronic
Pancreatic Neoplasms
Acute myelogenous leukemia
Lymphoma, small cleaved-cell, diffuse
Urinary Bladder Neoplasms
Breast Neoplasms
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Lymphatic Diseases
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Head and Neck Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Acute myelocytic leukemia
Lymphoma
Prostatic Neoplasms
Colorectal Neoplasms
Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009