ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer

Completed · Phase 1

Conditions studied: Neoplasms, Lymphoma

In brief

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

Key facts

Study ID

NCT01445522

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2008-12-03

Expected to finish

2012-07-03

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a Phase 0 study, and should have recovered to eligibility levels from any toxicities.
• Patients who have been administered ABT-888 as part of a single or limited dosing study, such as a Phase 0 study, should not be excluded from participating in this study solely because of receiving prior ABT-888.
• Patients who have received prior cyclophosphamide should not be excluded solely because of receiving prior cyclophosphamide.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with gliomas, symptomatic CNS metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with history of CNS metastases who have received treatment and whose CNS metastatic disease status has remained stable for greater than or equal to 3 months without steroids or anti-seizure medications may be eligible. These patients may be enrolled at the discretion of the principal investigator.
• Patients with a history of seizures.
• Patients with HIV who are taking protease inhibitors.
• Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, active peptic ulcer disease) are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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