Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia

May 4, 2007 updated by: Novacea

A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms

The purpose of this study is to find answers to the following questions:

  • What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
  • What are the side effects of AQ4N when given according to this schedule?
  • How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
  • Will AQ4N help treat lymphoid cancer?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients in this study will receive AQ4N one time every three weeks for a maximum of 24 weeks. Each patient will receive the same dose for the entire time he/she is on the study. However, some patients may receive a different dose than other patients depending upon when they enter the study.

When the study begins, the first three patients will receive a dose of 400 mg/m2. After they have all been observed for 2 weeks, and if side effects do not occur or are tolerable, another three patients will enter the study at a higher dose. The increase in dose may continue with new patient groups until side effects reach a point where they are not tolerated. At that point no higher doses will be tried and more patients will be allowed to enter at one or two lower doses where the side effects were tolerated.

Up to 55 patients will be entered in this study at up to 8 research centers in the United States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)

The following procedures will be completed at the time of screening and throughout the study: review of medical and cancer history, previous cancer treatments, and current medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a computed tomography scan (CT scan) and a bone marrow biopsy.

Study Type

Interventional

Enrollment

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University/ New York Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
  • Tumor specimen available for evaluation (please provide 10 unstained slides)
  • Relapse after receiving primary treatment and at least one salvage therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Laboratory test measurements
  • Females of childbearing potential must have a negative pregnancy test result within 3 days prior to the first dose and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
  • Older than 18 years of age
  • Available for periodic blood sampling

Exclusion Criteria:

  • Certain cardiac problems
  • Previous donor stem cell transplant
  • Known HIV, Hepatitis B, Hepatitis C infection
  • Previous chemotherapy, radiation or other investigational drug treatments within 4 weeks of first planned dose of study drug
  • Major surgery within four weeks of first planned dose of study drug
  • Any active viral, bacterial, or fungal infection within four weeks of first planned dose of study drug
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Survival
Response duration and time to tumor progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novacea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

April 27, 2005

First Submitted That Met QC Criteria

April 26, 2005

First Posted (Estimate)

April 27, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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