Phase
Condition
Vaginal Cancer
Carcinoma
Fallopian Tube Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Patients with histologically documented:
BRCA-positive ovarian cancer (documented deleterious BRCA1/2 mutation or aBRCAPRO score of greater than or equal to 30%)
primary peritoneal or ovarian high-grade serous carcinoma or fallopian tubecancer (no requirement for BRCA status)
triple-negative breast cancer (documented estrogen receptor (ER) negative,progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (Her2/neu) negative from the original pathology report if considered adequate, orper The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (47, 48)) with metastasis to distant sites
Low-grade lymphoid malignancies (NHL), as described below, whose disease hasprogressed following at least one line of standard therapy:
Follicle center lymphoma, follicular or diffuse-recurrent/refractory
Marginal zone B-cell lymphoma: splenic, nodal, extranodal (this includesmucosa-associated lymphoid tissue (MALT)) - recurrent/refractory
Lymphoplasmacytic lymphoma - recurrent/refractory
Small lymphocytic lymphoma (SLL) (absolute lymphocytes count below 5,000) Pathology must be confirmed by the registering institution. For patients who are eligiblefor the study due to a history of BRCA1/2 mutation, documented evidence of their mutationstatus must be provided prior to enrolling on the study.
Patients must have measurable disease, defined as at least one lesion that can beaccurately measured in at least one dimension (longest diameter to be recorded) asgreater than or equal to 20 mm with conventional techniques or as greater than orequal to 10 mm with spiral computed tomography (CT) scan.
Any prior therapy or radiotherapy must have been completed greater than or equal to 4weeks (greater than 6 weeks for nitrosoureas or mitomycin C) prior to enrollment onprotocol, and the participant must have recovered to eligibility levels from priortoxicity. Patients must be greater than or equal to 2 weeks since any investigationalagent administered as part of a Phase 0 study, and should have recovered toeligibility levels from any toxicities.
Patients who have had prior treatment with any PARP inhibitors are eligible unless thePARP inhibitor was administered in combination with cyclophosphamide.
Patients with bone metastases or hypercalcemia on bisphosphonate treatment areeligible to participate
Age greater than or equal to 18 years. Because no dosing or adverse event data arecurrently available on the use of ABT-888 in patients less than 18 years of age,children are excluded from this study, but may be eligible for future pediatric PhaseI combination trials.
Karnofsky performance status greater than or equal to 70%.
Life expectancy greater than 3 months.
Patients must have adequate organ and marrow function as defined below:
absolute neutrophil count greater than or equal to 1,500/microL (mcL)
platelets greater than or equal to 100,000/microL (mcL)
total bilirubin less than 1.5 times institutional upper limit of normal
Aspartate aminotransaminase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransaminase (ALT) serum glutamic pyruvic transaminase (SGPT)less than or equal to 2.5 times institutional upper limit of normal
creatinine less than 1.5 times institutional upper limit of normal OR
--creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels greater than or equal to 1.5 times institutional upper limit of normal.
The effects of ABT-888 on the developing human fetus are unknown. For this reason andbecause cyclophosphamide hydrochloride is known to be teratogenic, women ofchildbearing potential and men must agree to use adequate contraception (abstinence;female use of hormonal methods, or barrier methods of birth control; male use of acondom) prior to study entry, for the duration of study participation, and for 3months after completion of study. Because there is a risk for adverse events innursing infants secondary to treatment of the mother with cyclophosphamide,breastfeeding should be discontinued while the patient is on this trial and for 30days after completion of treatment on this trial. Should a woman become pregnant orsuspect she is pregnant while participating in this study, she should inform hertreating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
EXCLUSION CRITERIA:
Women who are pregnant or breastfeeding.
Patients with uncontrolled intercurrent illness including, but not limited to, ongoingor active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with study requirements.
Patients with germ cell and borderline ovarian epithelial tumors.
Patients who have received prior cyclophosphamide should not be excluded solelybecause of receiving prior cyclophosphamide.
Patients with history of central nervous system (CNS) metastases who have receivedtreatment and who have been on stable doses of anti-seizure medicine and had noseizures x 3 months will be eligible.
Patients with gastrointestinal conditions that might predispose for drugintolerability or poor drug absorption (e.g., inability to take oral medication or arequirement for intravenous (IV) alimentation, prior surgical procedures affectingabsorption, malabsorption syndrome, and active peptic ulcer disease) are excluded.Subjects with ulcerative colitis, inflammatory bowel disease, or a partial or completesmall bowel obstruction are also excluded, as are any patients who cannot swallow thecapsule whole. Capsules must not be crushed or chewed; nasogastric or gastrostomy tube (G-tube) administration is not allowed. INCLUSION OF WOMEN AND MINORITIES:
-Men and women of all races and ethnic groups are eligible for this trial.
Study Design
Study Description
Connect with a study center
Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
University of California, Davis
Davis, California 95616
United StatesSite Not Available
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892
United StatesSite Not Available
Mayo Clinic, Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
University of Nebraska Med. Ctr. Eppley Cancer Ctr.
Omaha, Nebraska 68198-5950
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210-1240
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030-4096
United StatesSite Not Available

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