A practice manager is a key point person for relaying information on clinical trials to the physicians, nurses, and navigators in the oncology practice. Here you will find basic information on several active trials that are currently recruiting patients, including contact information for the study investigators, the clinical trial reference number, and the locations of the study so you can be aware of studies being done near your practice location.
Nab-Paclitaxel/Gemcitabine or Carboplatin as First-Line Treatment for Triple Negative Metastatic Breast Cancer
Celgene is conducting a study in 3 centers in Arkansas, North Carolina, and Virginia to compare the safety and efficacy of nab-pac-litaxel in combination with either gemcitabine or carboplatin with the combination of gemcitabine and carboplatin as a first-line treatment in female subjects with triple-negative metastatic breast cancer.
Debra Barton, MD, the Associate Director of Clinical Trial Disclosure for Celgene and the director of this study, can be contacted at 888-260-1599 or clinicaltrialsdisclosure@cel gene.com.
Source: ClinicalTrials.gov
ABT-199 in Relapsed or Refractory Chronic Lymphocytic Leukemia with the 17p Deletion
This phase 2, open-label, multicenter study will evaluate the efficacy of ABT-199 in approximately 100 relapsed or refractory subjects with chronic lymphocytic leukemia (CLL) harboring 17p13 (TP53 locus) deletion. Subjects must be 18 years of age or older with a diagnosis of CLL that meets published 2008 International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute–Working Group criteria. For a list of inclusion/exclusion criteria, contact Cathy Nolan at 847-973-2404 or
Source: ClinicalTrials.gov
Safety and Efficacy Study of Enzalutamide in Patients with Advanced Androgen Receptor-Positive, Triple–Negative Breast Cancer
The purpose of this phase 2 study is to determine if enzalutamide is safe and effective in the treatment of patients 18 years of age and older with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not HER2 amplified. For a list of inclusion/exclusion criteria, contact Amy Peterson, MD, study chair, at 415-543-3470 or
Source: ClinicalTrials.gov
NovoTTF-100A with Bevacizumab (Avastin) in Patients with Recurrent Glioblastoma
NovoTTF-100A is a device and bevacizumab is a study drug that have both been approved by the US Food and Drug Administration for use as monotherapy in treating patients with glioblastoma multiforme (GBM). The NovoTTF-l00A is a portable, battery-operated device that produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.
The purpose of this open-label, phase 2 trial is to determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive adult patients (meaning they have never received bevacizumab), aged 22 years and older, with recurrent GBM as measured by 6-month progression-free survival.
The NovoTTF-100A treatment and bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic. For a list of inclusion/exclusion criteria, contact Manmeet Ahluwalia, MD, study chair, at 216-444-6145 or
Source: ClinicalTrials.gov
FOLFOX Plus Regorafenib in Patients with Unresectable or Metastatic Esophagogastric Cancer
The purpose of this phase 2 study is to evaluate the effects, good and/or bad, of the drug regorafenib with a
chemotherapy regimen (FOLFOX) in patients aged 18 years and older with histologically or cytologically confirmed metastatic or unresectable esophageal, gastroesophageal junction, or gastric adenocarcinoma.
For a list of inclusion/exclusion criteria, contact Yelena Janjigian, MD, principal investigator, at 646-888-4186. Reference the ClinicalTrials.gov identifier: NCT01913639. The study is sponsored by Memorial Sloan-Kettering Cancer Center and Bayer Corporation. The study locations are in Basking Ridge, New Jersey; Commack, New York; New York, New York; Rockville Centre, New York; and Sleepy Hollow, New York.
Source: ClinicalTrials.gov
Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients with Relapsed or Refractory Hematologic Malignancies
Patients aged 21 years and younger with relapsed or refractory leukemia or lymphoma will be recruited for this phase 1 study to determine whether the addition of a new drug—bendamustine—will be safe and efficacious to give with other chemotherapy drugs. This drug is approved by the US Food and Drug Administration for the treatment of other cancers in adults that are similar to those being studied in the research trial.
The primary objectives of the study are to establish the maximum tolerated dose of bendamustine in combination with clofarabine and etoposide in pediatric participants with hematologic malignancies, and to characterize the safety profile and dose-limiting toxicities of bendamustine in combination with clofarabine and etoposide. The secondary objectives are to estimate event-free survival at 4 months, to estimate minimal residual disease levels present at the end of each cycle of therapy in patients with leukemia, and to characterize the pharmacokinetic profile of bendamustine in the proposed regimen.
Bendamustine will be combined with clofarabine and etoposide in a 5-day cycle. Dexamethasone will be given to prevent capillary leak syndrome associated with clofarabine.
If the participant does not develop progressive disease or a dose-limiting toxicity during the first cycle, a second cycle may be administered as a bridge to transplant. Each cycle lasts 21 to 28 days (or until count recovery).
Concomitant intrathecal therapy can be given at the investigator’s discretion, but not on the same days
as chemotherapy. Recommendations are triple intrathecal therapy (methotrexate, hydrocortisone, cytarabine) weekly for patients with central nervous system (CNS)2 or CNS3 disease, and every 2 weeks for patients with CNS1 disease. Leucovorin may be given according to institutional guidelines.
The intent of this study design is for all patients to receive and complete 1 course of therapy. Patients who exhibit signs of disease progression or experience an unacceptable toxicity will be discontinued from the protocol treatment.
Patients with Hodgkin or non-Hodgkin lymphoma must meet 1 of the following criteria to participate in the trial: relapsing disease in second or greater relapse and measurable disease; or refractory disease failing to achieve complete remission (CR) with >2 induction or reinduction attempts. Patients with acute leukemia must meet 1 of the following criteria to participate in the trial: relapsing acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or acute biphenotypic leukemia in second or greater relapse; or refractory ALL, AML, or acute biphenotypic leukemia failing to achieve CR with ?2 induction or reinduction attempts. Participants with leukemia must have M2 or M3 marrow at the time of enrollment. Participants with M2 marrow must have definite cytogenetic, molecular, or immunophenotypic evidence of recurrent/refractory disease. Participants must not yet have reached their 22nd birthday.
For a list of inclusion/exclusion criteria, contact Deepa Bhojwani, MD, principal investigator, at 866-278-5833 or
Source: ClinicalTrials.gov
Assessing CUDC-427 When Given Twice Daily to Patients with Advanced and Refractory Solid Tumors or Lymphoma
This is a phase 1, open-label, dose-escalation study of CUDC-427 in patients aged 18 years or older with advanced or refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize proteins that prevent or interfere with cell death. The study is designed to assess the safety, including the maximum tolerated dose (MTD), the pharmacokinetics, and the anticancer activity of CUDC-427.
Sequential dose-escalation cohorts of oral CUDC-427 are planned. Subject enrollment and dose escalation will proceed according to a standard 3+3 design. In the absence of intolerable toxicity, each subject will receive a minimum of 1
cycle (21 days) of study treatment, and may continue to receive additional cycles until disease progression has been documented or other treatment discontinuation criteria have been met.
No intrasubject dose escalation will be allowed. During the dose- escalation phase, up to 3 additional subjects may be enrolled at previously cleared dose levels to better define the safety, tolerability, and activity of the study treatment. Similarly, an MTD expansion cohort of up to 12 evaluable subjects may also be enrolled; enrollment into this expansion cohort may be limited to a particular cancer type.
Safety and tolerability will be assessed by the incidence and severity of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.03). A Safety Review Committee comprised of the medical monitor, principal investigators, and sponsor representatives will be convened to review safety information and to decide on dose escalation and further subject enrollment.
The antitumor activity of study treatment will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or the Revised Response Criteria for Malignant Lymphoma as appropriate for each subject’s tumor type.
Exploratory biologic markers of CUDC-427 activity will be assessed in tumor samples (where available), peripheral blood mononuclear cells, and plasma.
For a list of inclusion/exclusion criteria, contact Lorrie Patterson at 877-691-7274 or asksarah@scre search.net; or Isabel Jimenez, RN, MSN at 210-593-5265 or
Source: ClinicalTrials.gov
Bortezomib for Low or Intermediate-1 Myelodysplastic Syndrome with p65 Activation
The goal of this phase 2 clinical research study is to learn if bortezomib can help to control myelodysplastic syndrome (MDS). Bortezomib is designed to block a protein that causes cells to grow, which may cause cancer cells to die. The safety of the drug will also be studied. Those found to be eligible to take part in this study will receive bortezomib as a subcutaneous injection on days 1, 4, 8, and 11 of each 21-day cycle.
This is an investigational study. Bortezomib is approved by the US Food and Drug Administration and commercially available to treat multiple myeloma and mantle cell lymphoma. Giving it to patients with MDS is investigational. Up to 40 participants, aged 18 years and older, will be enrolled in this study.
For a list of inclusion/exclusion criteria, contact Guillermo Garcia-Manero, principal investigator, at 713-745-3428. Reference the ClinicalTrials.gov identifier: NCT01891968. The study is sponsored by Millennium Pharmaceuticals, Inc. The study location is in Houston, Texas at the MD Anderson Cancer Center at The University of Texas.
Source: ClinicalTrials.gov