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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Novacea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00109356
First received: April 27, 2005
Last updated: May 4, 2007
Last verified: May 2007
  Purpose

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?

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
Drug: AQ4N (Chemotherapy)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms

Resource links provided by NLM:


Further study details as provided by Novacea:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Response duration and time to tumor progression
  • Time to treatment failure
  • Survival

Estimated Enrollment: 55
Study Start Date: March 2005
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00109356

Locations
United States, New York
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Novacea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00109356     History of Changes
Other Study ID Numbers: 021-002
Study First Received: April 27, 2005
Last Updated: May 4, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novacea:
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on October 19, 2014