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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00090727
• Other study ID #: 021-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 2, 2004
• Last updated: October 31, 2006
• Start date: August 2004

Study information

• Verified date: April 2005
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Neoplasms
• Non-Hodgkin's Lymphoma
• Solid Malignancies

Intervention

Drug:
• AQ4N

Locations

Country	Name	City	State
United States	Weiler Hospital of Albert Einstein College of Medicine	Bronx	New York
United States	Cancer Therapy & Research Center / Institute for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novacea

Country where clinical trial is conducted

United States,