A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum
Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes to give pembrolizumab to patients who have had further growth of their cancer after chemotherapy with a platinum agent, according to standard of care, and combine it with an experimental agent, sEphB4-HSA, which may have synergistic effect with pembrolizumab. It is hypothesized that the two drugs, in combination, will be more effective than either drug alone. The sEphB4-HSA was studied in various cancers and was found to be safe with its primary side effect being elevated blood pressure which may require blood pressure medication while receiving the drug. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) bladder cancer (or urothelial carcinoma) and have been treated with platinum-based chemotherapy in the past, this trial may be a treatment option
Not recruiting | Metastatic bladder cancer | Multisite
Phase II Study of Single Agent Regorafenib in Patients With Advanced/Metastatic Neuroendocrine Tumors
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) in advanced/metastatic in patients with
carcinoid or pancreatic islet cell tumors.
SECONDARY OBJECTIVES:
I. To assess overall survival and response rate in advanced/metastatic poor prognosis in
patients with carcinoid or pancreatic islet cell tumors.
II. To assess the toxicity of patients treated with regorafenib. III. To explore markers of
angiogenesis as they relate to outcome in carcinoid and pancreatic islet cell tumors.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Not recruiting | Neuroendocrine Tumors | Multisite
4P-12-1 A Randomized Phase II Trial of Dasatinib plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy
PRIMARY OBJECTIVES:
I. To compare the progression-free survival of men with metastatic castration-resistant
prostate cancer treated with abiraterone (abiraterone acetate) plus dasatinib to that of men
treated with abiraterone alone.
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of the combination, as well as the rate of
prostate-specific antigen (PSA) response, objective responses, and changes in circulating
tumor cell (CTC) numbers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive
abiraterone acetate 1000 mg orally (PO) once daily (QD) and prednisone 5 mg PO twice daily
(BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
ARM B: Patients receive abiraterone acetate and prednisone as patients in arm A. Patients
also receive dasatinib 100 mg PO QD on days 1-28. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Combined Exercise Program for Early Breast Cancer Survivors
PRIMARY OBJECTIVES:
I. To determine whether a 16-week exercise intervention will improve components of
metastasis (MetS) in breast cancer survivors soon after completion of cancer-related
treatments by measuring changes in body composition, waist circumference, blood pressure,
and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c
(HbA1c).
II. To determine whether a 16-week exercise intervention will improve physical fitness in
breast cancer survivors soon after completion of cancer-related treatments by measuring
cardiorespiratory fitness and muscle strength.
III. To assesses the feasibility of a supervised exercise intervention in early breast
cancer survivors.
IV. To determine whether a 16-week exercise intervention will result in a reduction in
adipose tissue inflammation in obese breast cancer survivors soon after completion of
cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.
V. To determine whether breast cancer survivors can maintain positive benefits of an
exercise intervention following a 12-week follow-up period by measuring changes in body
composition, waist circumference, blood pressure, and serum levels of insulin, glucose,
lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength.
OUTLINE:
Patients are randomized to 1 of 2 arms.
Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.
Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes
thrice weekly and are encouraged to participate in a home-based exercise session over 30-45
minutes once weekly for 16 weeks.
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