Clinical Trials

Alternate approaches for clinical stage II or III Estrogen Receptor positive breast cancer Neoadjuvant Treatment (ALTERNATE) in postmenopausal women: a Phase III Study

Disease/Site: Breast
Protocol Number: Alliance A011106
Phase: III

PI/Coordinator: Dr. Muzaffar/ Renee Coghill
Open Date: 10/19/2015
Contact Information: 252-744-5723

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Position Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

Disease/Site: Breast
Protocol Number: Alliance A011202
Phase: III

PI/Coordinator: Dr. Harris/ Renee Coghill
Open Date: 5/4/2015
Contact Information: 252-744-5723

IDEA (Individualized Decisions for Endocrine therapy Alone): A prospective, single arm cohort study of patients receiving endocrine therapy alone (without radiotherapy) after breast conserving surgery for early-stage, post menopausal breast cancer patients whose tumors have favorable biologic features

Disease/Site: Breast
Protocol Number: IDEA
Phase: NA

PI/Coordinator: Dr. Harris/ Renee Coghill
Open Date: 3/23/2015
Contact Information: 252-744-5723

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)

Disease/Site: Breast
Protocol Number: ONT-380-206
Phase: II

PI/Coordinator: Dr. Muzaffar/ Renee Coghill
Open Date: 12/19/2016
Contact Information: 252-744-5723

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Disease/Site: Breast
Protocol Number: NRG-BR003
Phase: III

PI/Coordinator: Dr. Muzaffar/ Renee Coghill
Open Date: 4/4/2016
Contact Information: 252-744-5723

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Disease/Site: Breast
Protocol Number: NSABP B-51
Phase: III

PI/Coordinator: Dr. Harris/ Renee Coghill
Open Date: 3/5/2015
Contact Information: 252-744-5723

CP-MGAHH22-04 - A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs. Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

Disease/Site: Breast
Protocol Number: SOPHIA
Phase: III

PI/Coordinator: Muzaffar/ Renee Coghill
Open Date: 8/1/2017
Contact Information: 252-744-5723

A study looking at targeted therapy according to tumor markers for people with meningiomas: Phase II Trial of SMO/AKT/NF2 inhibitors in progressive meningiomas with SMO/AKT/NF2 mutations

Disease/Site: Brain
Protocol Number: Alliance A071401
Phase: II

PI/Coordinator: Lepera/ Renee Coghill
Open Date: 1/13/2016
Contact Information: 252-744-5723

Autologous Tumor Cells Modified to Exhibit αGal Antigens as Anti-Cancer Vaccines

Disease/Site: Malignant Hematology
Protocol Number: Wang
Phase:

PI/Coordinator: Dr. Wiley/Susan Eubanks
Open Date: 2/5/2016
Contact Information: 252-744-1015

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Disease/Site: ALL
Protocol Number: ALL08B1 (age<31)
Phase: -

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 1/21/2015
Contact Information: 252-744-5404

A Randomized Open-Label Trial of Caspofungin versus Fluconozole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

Disease/Site: AML
Protocol Number: ACCL0933 Pediatrics
Phase:

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 1/22/2014
Contact Information: 252-744-5404

Renal Tumors clasification, Biology and Banking Study

Disease/Site: Kidney
Protocol Number: AREN03B2 Pediatrics
Phase:

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 12/31/2006
Contact Information: 252-744-5404

A Phase III Randomized Trial Investigating Bortezomib on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLY)

Disease/Site: T-ALL
Protocol Number: AALL1231
Phase: III

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 3/9/2016
Contact Information: 252-744-5404

Protocol for Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)

Disease/Site: Pediatric Oncology Registry
Protocol Number: ACCRN07
Phase:

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 4/27/2015
Contact Information: 252-744-5404

Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients with Rhabdomyosarcoma or Other Soft Tissue Sarcoma

Disease/Site: Pediatric Biology and Banking
Protocol Number: D9902
Phase:

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 9/23/2016
Contact Information: 252-744-5404

A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Clofarabine (IND#73789, NSC#606869) in the Very High Risk Stratum

Disease/Site: B-ALL
Protocol Number: AALL1131
Phase: III

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 12/12/2015
Contact Information: 252-744-5404

A Disease Registry for Patients with Chronic Lymphocytic Leukemia

Disease/Site: CLL
Protocol Number: informCLL
Phase:

PI/Coordinator: Dr. Darla Liles/Bolaji Babatunde
Open Date: 2/2/2017
Contact Information: 252-744-0380

The Myelodysplastic Syndromes (MDS) and AML Registry

Disease/Site: AML & MDS
Protocol Number: Connect
Phase: NA

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 11/18/2015
Contact Information: 252-744-4924

PIPER: A Prospective, Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

Disease/Site: Hematology/ Oncology
Protocol Number: PIPER
Phase: IV

PI/Coordinator: Dr. Darla Liles/Kaitlyn Walker
Open Date: 10/10/2016
Contact Information: 252-744-0456

Randomized Phase III Trial of Lenalidomide Versus Observatoin Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma

Disease/Site: Multiple Myeloma
Protocol Number: ECOG-ACRIN E3A06
Phase: III

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 5/10/2016
Contact Information: 252-744-4924

A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib vs. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide and Proteasome Inhibitor-Based Therapy

Disease/Site: Multiple Myeloma
Protocol Number: Alliance A061202
Phase: II

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 8/10/2016
Contact Information: 252-744-4924

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST – Genotype Screening component)

Disease/Site: Lung
Protocol Number: Alliance A151216 (ALCHEMIST)
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completed Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Disease/Site: Lung
Protocol Number: Alliance A081105 (ALCHEMIST)
Phase: II

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

A Phase III Double blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Disease/Site: Lung
Protocol Number: ECOG-Acrin E4512 (ALCHEMIST)
Phase: III

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 7/30/2015
Contact Information: 252-744-1015

Phase II trial regarding the effect of comprehensive symptom management on inflammation and survival in metastatic lung cancer

Disease/Site: Lung
Protocol Number: INSYNC
Phase: -

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 9/24/2014
Contact Information: 252-744-1015

A Phase II Study of Definitive Concurrent Radiation Therapy with Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-Operable Non-Small Cell Lung Cancer

Disease/Site: Lung
Protocol Number: LJCC 2014-01
Phase: II

PI/Coordinator: Dr. Paul R. Walker/ Susan Eubanks
Open Date: 10/16/2014
Contact Information: 252-744-1015

Predictive value of the modified glasgow prognostic score among patients undergoing immunotherapy with PD-1 targeted agents

Disease/Site: Lung
Protocol Number: P-MAIT
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/ Amanda Wetherington
Open Date: 11/11/2015
Contact Information: 252-744-0320

SNAP: Prognostic Value of the Modified Glasgow Prognostic Score In A North American Population of Thoracic Oncology Patients

Disease/Site: Lung
Protocol Number: SNAP
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/ Amanda Wetherington
Open Date: 10/20/2015
Contact Information: 252-744-0320

BDX-00146: An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer

Disease/Site: Lung
Protocol Number: BDX-00146
Phase:

PI/Coordinator: Dr. Paul R. Walker/ Kaitlyn Walker
Open Date: 10/3/2016
Contact Information: 252-744-0456

Trends of Circulating Tumor DNA Levels in Patients Treated with Immune Therapy

Disease/Site: Lung
Protocol Number: CLIP-IT
Phase: NA

PI/Coordinator: Dr. Meera Yogarajah/ Amanda Wetherington
Open Date: 4/10/2017
Contact Information: 252-744-0320

Identification of Biomarkers in Lung Cancer Patients Treated with Immunotherapy

Disease/Site: Lung
Protocol Number: Yang
Phase: NA

PI/Coordinator: Dr. Li/ Susan Eubanks
Open Date: 8/30/2016
Contact Information: 252-744-1015

Carolina Senior: UNC Registry For Older Patients

Disease/Site: Cancer Registry
Protocol Number: LCCC0916
Phase: NA

PI/Coordinator: Dr. Paul R. Walker/Any Available
Open Date: 7/23/2013
Contact Information: 252-744-1015

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Trial of the Effects of of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non- Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Disease/Site: Mucositis
Protocol Number: Galera GC4419
Phase: II

PI/Coordinator: Dr. Sharon Gordon/Debra Peaden
Open Date: 11/6/2015
Contact Information: 252-737-7126

A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment with Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath R120 Catheter and Assessment of the Performance of the RenovoCath R120 Catheter

Disease/Site: Pancreas
Protocol Number: RenovoCath
Phase:

PI/Coordinator: Dr. Emmanueal Zervos/ Kaitlyn Walker
Open Date: 3/28/2016
Contact Information: 252-744-0456

A Phase III Trial Evaluating Both Erlotinib And Chemoradiation As Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma

Disease/Site: Pancreas
Protocol Number: RTOG0848
Phase: III

PI/Coordinator: Dr. Pamela Lepera/ Renee Coghill
Open Date: 5/9/2011
Contact Information: 252-744-5723

A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

Disease/Site: Rectal
Protocol Number: ALLIANCE N1048 (PROSPECT)
Phase: II/III

PI/Coordinator: Dr. Paul R. Walker/ Renee Coghill
Open Date: 10/1/2014
Contact Information: 252-744-5723

A Phase II, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Disease/Site: AIHA
Protocol Number: C-935788-053
Phase: II

PI/Coordinator: Dr. Darla Liles/ Amanda Wetherington
Open Date: 5/27/2016
Contact Information: 252-744-0320

Thrombotic Thrombocytopenic Purpura (TTP) Registry

Disease/Site: TTP Registry
Protocol Number: TTP Registry
Phase: NA

PI/Coordinator: Dr. Darla Liles/ Any Available
Open Date: 5/22/2015
Contact Information: 252-744-1015

A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of Rivipansel (GMI-1070) in the treatment of vaso-occlusive crisis in hospitalized subjects with sickle cell disease

Disease/Site: Sickle Cell
Protocol Number: B5201002
Phase: III

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 8/1/2016
Contact Information: 252-744-4924

An Open-Label Extension Study to Evaluate the Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects with Sickle Cell Disease

Disease/Site: Sickle Cell
Protocol Number: B5201003
Phase: III

PI/Coordinator: Dr. Darla Liles/ Denise Brigham
Open Date: 2/23/2017
Contact Information: 252-744-4924

Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Disease/Site: B-ALL
Protocol Number: AALL0932
Phase:

PI/Coordinator: Dr. Beng Fuh/Mary Lynn Harrell
Open Date: 4/25/2012
Contact Information: 252-744-5404

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