Status:
UNKNOWN
Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
Lead Sponsor:
Novacea
Conditions:
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 effec...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00109356
Start Date
March 1 2005
End Date
March 1 2007
Last Update
May 7 2007
Active Locations (1)
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1
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, New York, United States, 10021