PRIMARY OBJECTIVES: I. To evaluate the dose limiting toxicities and determine the maximum tolerated dose/recommended phase 2 dose of the combination of guadecitabine and durvalumab. (Dose escalation part) II. To evaluate the objective response rate (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) for the combination of guadecitabine and...
PRIMARY OBJECTIVES: I. To identify a safe dose of guadecitabine in combination with atezolizumab and to assess the safety and tolerability of the combination in patients with myelodysplastic syndrome (MDS) who are refractory to or have lost their confirmed response to one or more hypomethylating agents (HMAs) and in patients...
PRIMARY OBJECTIVES: I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy. II. To determine the toxicity of postoperative SBRT at a dose...
PRIMARY OBJECTIVES: I. To estimate the rate of developing parastomal hernia detected either clinically or radiologically in patients with radical cystectomy and ileal conduit, with or without mesh. SECONDARY OBJECTIVES: I. To estimate the rate of developing symptomatic parastomal hernia requiring surgical intervention in patients with radical cystectomy and ileal...
BACKGROUND Recent investigations have shown that mutations in epigenetic regulators are common, both in the apparently normal hematopoiesis of the elderly and in patients (pts) with myeloid cancers. It was long anticipated that DNA methylation was a permanent silencing mark, but with the discovery of the ten eleven translocation (TET)...
PRIMARY OBJECTIVE: I. To determine if the combination of berzosertib (M6620) with topotecan hydrochloride (topotecan) will result in an improvement in progression-free survival (PFS) compared to topotecan alone in patients with relapsed small cell lung cancer (SCLC). SECONDARY OBJECTIVE: I. To determine the objective response rate (ORR) and overall survival...
PRIMARY OBJECTIVES: I. To assess the difference in whole-neck computed tomography perfusion (WNCTP) parameters (blood volume [BV], blood flow [BF], capillary permeability [CP] and mean transit time [MTT]) between head and neck tumor masses (benign or malignant) and adjacent normal skeletal muscle within the same patient. II. To assess whether...
PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF...
PRIMARY OBJECTIVES: I. To compare overall survival (OS) in patients with untreated, advanced biliary cancers treated with gemcitabine hydrochloride (gemcitabine) and cisplatin (GC) versus those treated with gemcitabine, cisplatin, and nab-Paclitaxel (GCN). SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients treated with GC versus GCN. II. To compare...
PRIMARY OBJECTIVE: I. To evaluate the toxicities of KRT-232 (AMG-232) in combination with decitabine (20 mg/m^2 for 10 days), and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of KRT-232 (AMG-232) in combination with a standard dose of decitabine. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic (PK)...
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...
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose (RP2D). II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated with FID-007. SECONDARY OBJECTIVES: I. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common...
PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention...
PRIMARY OBJECTIVE: I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive sentinel lymph...
PRIMARY OBJECTIVE: I. To determine the frequency of patients responding (response rate) to talimogene laherparepvec monotherapy. SECONDARY OBJECTIVES: I. To determine the local response rate to talimogene laherparepvec in injected tumors. II. To determine the response rate to talimogene laherparepvec + nivolumab (NIVO). III. To identify potential pre-treatment and on-treatment...
PRIMARY OBJECTIVES: I. To ascertain if time to surgical bed failure is increased with fractionated stereotactic radiosurgery (FSRS) compared to single-fraction stereotactic radiosurgery (SSRS) in patients with resected brain metastasis. SECONDARY OBJECTIVES: I. To ascertain if there is better emotional well-being at 9 months as assessed by the Functional Assessment...
The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group)...
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of berzosertib (M6620) in combination with irinotecan hydrochloride (irinotecan) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To estimate the safety and tolerability of M6620 in combination with irinotecan. II. To document anti-tumor...
PRIMARY OBJECTIVES: I. Determine the dose of anetumab ravtansine that is safe in combination with MK-3475 (pembrolizumab) to be used in the randomized phase 2 study. (Phase I safety lead-in) II. Determine if the overall response rate of the combination of anetumab ravtansine and MK-3475 (pembrolizumab) is superior to MK-3475...
PRIMARY OBJECTIVES: I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies. II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically...
PRIMARY OBJECTIVE: I. To assess the objective response rate, defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy with cabozantinib S-malate (XL184 [cabozantinib]), nivolumab, and ipilimumab (CaboNivoIpi). SECONDARY OBJECTIVES: I. To assess duration...
PRIMARY OBJECTIVES: I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB >= 4 cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection. SECONDARY OBJECTIVES: I. To evaluate and compare disease-free survival (DFS) associated with crizotinib....
PRIMARY OBJECTIVES: I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care. SECONDARY OBJECTIVES: I. To compare cumulative direct healthcare costs through 48 weeks...
PRIMARY OBJECTIVES: I. To determine whether binary changes (increase versus [vs.] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS). SECONDARY OBJECTIVES: I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS. II....
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced...
