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

• Status: Unknown status
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 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?

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novacea
• Treatments: AQ4N

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