ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer
Status:
Completed
Trial end date:
2012-07-03
Target enrollment:
Participant gender:
Summary
Background:
- Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the
treatment of certain cancers. It works by causing DNA damage, resulting in cell death,
including cancer cells.
- ABT-888 is an experimental drug that has been given to a small number of patients. It
works by preventing DNA repair in tumor cells.
Objectives:
- To test the safety of the combination of ABT-888 and CP, and to determine the dose of
each drug that can be given together to patients with cancer.
- To see how the body handles ABT-888 when given together with CP
- To evaluate the anti-tumor response of the drug combination.
Eligibility:
- Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic leukemia)
whose disease does not respond to standard treatments.
Design:
- Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose
level assigned to the individual patient.
- Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP
for 14 days only.)
- Patients undergo tests and procedures periodically during the study, including:
- Clinic visit and physical examination at the beginning of each cycle
- Blood and urine tests, electrocardiogram, measurement of vital signs
- CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment
- Tumor biopsies (optional)
- Bone marrow aspiration and biopsy