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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by Novacea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00090727
First received: September 2, 2004
Last updated: October 31, 2006
Last verified: April 2005
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00090727     History of Changes
Other Study ID Numbers: 021-001
Study First Received: September 2, 2004
Last Updated: October 31, 2006
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

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

ClinicalTrials.gov processed this record on August 20, 2014