Protocol Alert

Protocol Alert

14 Protocol Alert New clinical trials recently added to the National Cancer Institute’s database oncology-times.com • BRAIN/CNS TUMORS and Cyclophosphamide in Treating ENDOMETRIAL CANCER Phase: Phase II, Phase I Light Sedation or Intubated Patients with Stage I-III Triple- Levonorgestrel-Releasing Type: Treatment General Anesthesia in Reducing Negative Breast Cancer Intrauterine System with or without Age: 18 and over Complications and Length of Phase: Phase II Everolimus in Treating Patients with Trial IDs: SGN35-016, Hospital Stay in Patients With Brain Type: Treatment Atypical Hyperplasia or Stage IA NCI-2013-00461, NCT01874054 Cancer Undergoing Craniotomy Age: 18 to 70 Grade 1 Endometrial Cancer Phase: Phase IV Trial IDs: 2014-BRST-TNBC-LQT, Phase: Phase II Safety, Tolerability, and Efficacy of October 10, 2015 Type: Supportive care, Treatment NCI-2015-01416, STUDY00002467, Type: Biomarker/Laboratory analysis, TAK-659 in Adults With Relapsed • Age: 19 and over NCT02413320 Treatment or Refractory Acute Myelogenous Trial IDs: OSU-12161, NCI-2014- Age: 18 and over Leukemia (AML) 01110, 2014C0007, NCT02193568 Trial IDs: 2014-0944, Phase: Phase II, Phase I CERVICAL CANCER NCI-2015-00919, NCT02397083 Type: Treatment Pazopanib Hydrochloride and Age: 18 and over BREAST CANCER Topotecan Hydrochloride in Treating Trial IDs: C34002, NCI-2015-00064, Study to Evaluate the Efficacy and Patients with Stage IVB or Recurrent HEAD & NECK/ U1111-1163-2185, NCT02323113 Safety of Eribulin Mesylate in Cervical Cancer ORAL CANCER Combination With Pembrolizumab Phase: Phase II Photodynamic Therapy With HPPH A Study of Duvelisib in Combination Oncology Times in Subjects With Metastatic Triple- Type: Biomarker/Laboratory analysis, in Treating Patients With Squamous With Rituximab or Obinutuzumab in Negative Breast Cancer (mTNBC) Treatment Cell Carcinoma of the Oral Cavity Subjects With Previously Untreated Phase: Phase II, Phase I Age: 18 and over Phase: Phase II CD20+ Follicular Lymphoma Type: Treatment Trial IDs: 2014-0625, Type: Biomarker/Laboratory analysis, (CONTEMPO) Age: 18 and over NCI-2015-00211, NCT02348398 Treatment Phase: Phase II, Phase I Trial IDs: E7389-M001-218, Age: 18 and over Type: Biomarker/Laboratory analysis, NCI-2015-01436, KEYNOTE-150, Trial IDs: I 246513, NCI-2014-00756, Treatment NCT02513472 COLORECTAL CANCER NCT02119728 Age: 18 and over A Study Comparing the Efficacy and Trial IDs: IPI-145-19, Hypofractionated Regional Nodal Safety of RO5520985 and FOLFOX Surgery with or without Stereotactic NCI-2015-01462, Radiation Therapy in Treating Older With Bevacizumab and FOLFOX in Body Radiotherapy in Treating Patients NCT02391545 Patients with Breast Cancer Who with Previously-Irradiated Have Undergone Surgery Head and Neck Cancer Ruxolitinib Phosphate or Dasatinib Phase: Phase II Phase: Phase II with Chemotherapy in Treating Type: Biomarker/Laboratory analysis, Type: Treatment Patients with Relapsed or Refractory Treatment Age: 18 and over Philadelphia Chromosome-Like Age: 50 and over Trial IDs: 14-151, NCI-2015- Acute Lymphoblastic Leukemia Trial IDs: MCC-15-10994, 01424, NCT02516969 Phase: Phase II, Phase I NCI-2015-01317, NCT02515110 Type: Treatment Safety And Efficacy Age: 10 and over Panitumumab, Paclitaxel Albumin- Study Of Palbociclib Trial IDs: 2014-0521, Stabilized Nanoparticle Formulation, Plus Cetuximab Versus NCI-2015-00779, NCT02420717 and Carboplatin in Treating Cetuximab To Treat Head Patients with HER2-Negative And Neck Cancer Akt/ERK Inhibitor ONC201 in Primary Inflammatory Breast Phase: Phase II Treating Patients with Relapsed or Cancer Receiving Combination Type: Treatment Refractory Mantle Cell Lymphoma, Chemotherapy and Surgery Age: 18 and over Diffuse Large B-cell Lymphoma, or Phase: Phase II Trial IDs: A5481044, NCI- Transformed Large Cell Lymphoma Type: Biomarker/Laboratory analysis, 2015-01296, 2015-000515- Phase: Phase II, Phase I Treatment 41, NCT02499120 Type: Treatment Age: 18 and over Patients With Untreated Metastatic Age: 18 and over Trial IDs: 2008-0372, Colorectal Cancer (McCAVE) Azacitidine in Measuring Tumor Trial IDs: 2014-0630, NCI-2015- NCI-2012-00935, NCI-2010-02235, Phase: Phase II Response in Patients with HPV 00706, NCT02420795 NCT01036087 Type: Treatment Positive or Negative Head and Neck Age: 18 and over Squamous Cell Carcinoma That Can Tocladesine in Treating Patients with Metformin Hydrochloride in Trial IDs: BP29262, Be Removed by Surgery Relapsed or Refractory Acute Myeloid Reducing Treatment-Related NCI-2014-01282, Phase: Phase II Leukemia Neuropathy in Patients with Stage NCT02141295 Type: Treatment Phase: Phase II, Phase I I-IV Breast Cancer Undergoing Age: 18 and over Type: Biomarker/Laboratory analysis, Treatment with Paclitaxel Study of Pembrolizumab in Trial IDs: 1404013771, Treatment Phase: Phase II Combination With Chemotherapy NCI-2015-01437, 200 FR. 4 (2012-1), Age: 18 and over Type: Supportive care for Patients With Advanced NCT02178072 Trial IDs: 14269, NCI-2015-00871, Age: Over 18 Colorectal Cancer 116608, 120003, NCT02509546 Trial IDs: 2014-0438, Phase: Phase II NCI-2015-00510, NCT02360059 Type: Treatment LEUKEMIA/ An Efficacy and Safety Study of Age: 18 and over LYMPHOMA/MDS Decitabine (DACOGEN) Plus JNJ- Carboplatin and Docetaxel or Trial IDs: HCRN GI14-186, Study of Brentuximab Vedotin 56022473 (Anti CD123) Versus Carboplatin and Paclitaxel Followed NCI-2015-01466, Combined With Bendamustine in Decitabine (DACOGEN) Alone in by Doxorubicin Hydrochloride NCT02375672 Patients With Hodgkin Lymphoma Participants With Acute Myeloid 15 PROTOCOL ALERT Treating Patients with Advanced Trial IDs: HM-EMSI-202, NCI-2015- Cell Transplant in Treating Patients Oncology Times Continued from page 14 Refractory Solid Tumors or 01440, NCT02485652 With Multiple Myeloma Lymphomas Phase: Phase II Leukemia (AML) Ineligible for Phase: Phase II Type: Biomarker/Laboratory analysis, Intensive Chemotherapy Type: Biomarker/Laboratory analysis, MELANOMA Treatment Phase: Phase II Treatment Interleukin-12 Gene Electroporation Age: 18 to 72 Type: Treatment Age: 18 and over Therapy and Pembrolizumab in Trial IDs: 11-12-434, Age: 65 and over Trial IDs: EAY131, NCI-2015-00054, Treating Patients with Locally NCI-2013-01207, 11-102, Trial IDs: CR107273, NCI-2015-01326, EAY131-A, EAY131-B, EAY131-E, Advanced or Metastatic Melanoma NCT01605032 56022473AML2002, NCT02472145 EAY131-F, EAY131-G, EAY131-H, Phase: Phase II • EAY131-Q, EAY131-R, EAY131-U, Type: Biomarker/Laboratory analysis, Panobinostat, Gemcitabine October 10, 2015 Meloxicam and Filgrastim in EAY131-V, NCT02465060 Treatment Hydrochloride, Busulfan, and Collecting Peripheral Blood Stem Age: 18 and over Melphalan before Stem Cell Cells for Transplant in Patients With FLT PET/CT in Measuring Response Trial IDs: CC #15852, NCI-2015- Transplant in Treating Patients with Multiple Myeloma or Non-Hodgkin in Patients with Previously Untreated 01300, 133438, 15852, NCT02493361 Refractory or Relapsed Multiple Lymphoma Acute Myeloid Leukemia Myeloma Phase: Phase II Phase: Phase II Pembrolizumab, Standard Phase: Phase II Type: Treatment Type: Diagnostic, Treatment Chemotherapy, Tumor Infiltrating Type: Biomarker/Laboratory analysis, Age: 18 to 75 Age: 18 and over Lymphocytes, and High- or Low-Dose Treatment • oncology-times.com Trial IDs: IUCRO-0419, NCI-2014- Trial IDs: EAI141, Aldesleukin in Treating Patients with Age: 18 to 65 00470, NCT02078102 NCI-2015-00328, Metastatic Melanoma Trial IDs: 2014-0516, NCI-2015- NCT02392429 Phase: Phase II 01308, NCT02506959 Augmented Berlin-Frankfurt- Type: Biomarker/Laboratory analysis, Munster Therapy and Ofatumumab Donor Hematopoietic Stem Cell Treatment Sotatercept in Increasing Bone in Treating Patients with B-cell Transplant and Combination Age: 18 and over Mineral Density in Patients with Acute Lymphoblastic Leukemia or Chemotherapy as Initial Salvage Trial IDs: 2014-0922, NCI-2015- Multiple Myeloma with Complete Lymphoblastic Lymphoma Therapy in Treating Patients with 01395, NCT02500576 or Very Good Partial Response after Phase: Phase II Acute Myeloid Leukemia Refractory Previous Treatment Type: Treatment to High-Dose Cytarabine-Based Phase: Phase II Age: 12 to 30 Induction Chemotherapy MYELOMA Type: Biomarker/Laboratory analysis, Trial IDs: 2014-0396, NCI-2015- Phase: Phase II Busulfan, Melphalan, and Supportive care 00967, NCI-2010-01164, NCI-2012- Type: Treatment Bortezomib Before First-Line Stem Age: Over 18 01650, NCT02419469 Age: 18 to 60 continued on page 16 Trial IDs: 2014-0358, NCI-2015- Bendamustine Hydrochloride, 00849, NCT02441803 Obinutuzumab, and Dexamethasone in Treating Older Patients with Study of Efficacy and Safety of Diffuse Large B-cell Lymphoma CTL019 in Adult DLBCL Patients Phase: Phase II Phase: Phase II To Reach OT: Type: Biomarker/Laboratory analysis, Type: Treatment Treatment Age: 18 and over n Editorial, Permissions, or n Classified Advertising: Age: 70 and over Trial IDs: CCTL019C2201, NCI- Publishing Matters: Joe Anzuena National Account Trial IDs: IRB14-1120, NCI-2015- 2015-01461, 2014-003060-20, Oncology Times Manager Wolters Kluwer Health 00355, NCT02420210 NCT02445248 333 Seventh Ave. 19th Fl. Two Commerce Square New York, NY 10001 2001 Market Street Philadelphia, Pembrolizumab in Treating Patients [email protected] PA 19103 215 521-8532 with Relapsed or Refractory Chronic LUNG CANCER fax 215 701-2410 Lymphocytic Leukemia or Other Erlotinib Hydrochloride and Hsp90 n Joe.Anzuena@ wolterskluwer.com Low-Grade B-Cell Non-Hodgkin Inhibitor AT13387 in Treating Advertising Sales:

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