Background:
- The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing
deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment
drug that works by causing DNA damage in cells, including cancer cells, resulting in cell
death. However, because cyclophosphamide has strong and unpleasant side effects, researchers
are interested in finding drugs that can be given in combination with cyclophosphamide that
will allow a lower dose of cyclophosphamide to be given with similar effects. The combination
of ABT-88 and cyclophosphamide may be an effective treatment for some types of cancer, such
as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that often do not
respond to standard therapies.
Objectives:
- To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and
breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2)
BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian tube
cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy); or (3)
low grade non-Hodgkin's lymphoma.
Design:
- Participants will be screened with a full medical history and physical examination,
blood and urine tests, and tumor imaging studies. Participants will be divided into two
groups with different treatment subgroups.
- Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or
ovarian high-grade serous carcinoma, or fallopian tube cancer
- Participants will receive either the combination of ABT-888 and cyclophosphamide, or
cyclophosphamide alone.
- Participants will take the study drug by mouth once a day for 21-day cycles of
treatment, and will keep a diary to record drug doses and any side effects.
- Participants will have clinic visits with blood and urine tests, imaging studies, and
other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other
cycles.
- Group 2: Participants who have triple-negative breast cancer or non-Hodgkin's lymphoma
- Participants will receive either the combination of ABT-888 and cyclophosphamide, or
cyclophosphamide alone.
- Participants will take the study drug by mouth once a day for 21-day cycles of
treatment, and will keep a diary to record drug doses and any side effects.
- Participants will have clinic visits with blood and urine tests, imaging studies, and
other examinations on days 1, 2, 7, and 14 of cycle 1, and on the first day of all other
cycles.
- Participants receiving only cyclophosphamide who show signs of disease progression after
tumor imaging studies can receive the combination of ABT-888 with cyclophosphamide.
- Treatment will continue as long as participants tolerate the drugs and the disease does
not progress.