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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-03-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AQ4N (Chemotherapy)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Weill Medical College of Cornell University/ New York Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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021-002

Identifier Type: -

Identifier Source: org_study_id