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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090727
Recruitment Status : Unknown
Verified April 2005 by Novacea.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2004
Last Update Posted : November 2, 2006
Information provided by:

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

Condition or disease Intervention/treatment Phase
Solid Malignancies Non-Hodgkin's Lymphoma Drug: AQ4N Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
Study Start Date : August 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090727

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 Identifier: NCT00090727     History of Changes
Other Study ID Numbers: 021-001
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: April 2005

Keywords provided by Novacea:
chronic lymphocytic leukemia
colorectal cancer
pancreatic cancer
acute myelogenous leukemia
head and neck cancer
breast cancer
prostate cancer
ovarian cancer
bladder cancer

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases