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: Muzaffar/ Renee Coghill

Enrolled: 2
Target Accrual: 3
YTD: 1

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: Harris/ Renee Coghill

Enrolled: 1
Target Accrual: 10
YTD: 1

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: Harris/Renee Coghill

Enrolled: 7
Target Accrual: 25
YTD: 0

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: Muzaffar/Renee Coghill

Enrolled: 0
Target Accrual: 2
YTD: 0

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: Muzaffar/Renee Coghill

Enrolled: 0
Target Accrual: 4
YTD: 0

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: Harris/Renee Coghill

Enrolled: 3
Target Accrual: 10
YTD: 0

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

Enrolled: 0
Target Accrual: 2
YTD: 0

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

Enrolled: 1
Target Accrual: 2
YTD: 1

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

Disease/Site: Malignant
Protocol Number: Wang
Phase:
PI/Coordinator: Wiley/Susan Eubanks

Enrolled: 3
Target Accrual:
YTD: 1

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Disease/Site: ALL
Protocol Number: ALL08B1 (age<31)
Phase: -
PI/Coordinator: Hucks/Mary Lynn Harrell

Enrolled: 17
Target Accrual: 20
YTD: 0

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: Fuh/Mary Lynn Harrell

Enrolled: 1
Target Accrual:
YTD: 0

Renal Tumors clasification, Biology and Banking Study

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

Enrolled: 4
Target Accrual:
YTD: 1

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: Fuh/Mary Lynn Harrell

Enrolled: 3
Target Accrual:
YTD: 0

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: Fuh/Mary Lynn Harrell

Enrolled: 30
Target Accrual:
YTD: 1

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:

Enrolled: 1
Target Accrual:
YTD: 1

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: Fuh/Mary Lynn Harrell

Enrolled: 10
Target Accrual:
YTD: 0

A Disease Registry for Patients with Chronic Lymphocytic Leukemia

Disease/Site: CLL
Protocol Number: informCLL
Phase:
PI/Coordinator: Liles/Bolaji Babatunde

Enrolled: 4
Target Accrual: 20
YTD: 4

The Myelodysplastic Syndromes (MDS) and AML Registry

Disease/Site: AML & MDS
Protocol Number: Connect
Phase: NA
PI/Coordinator: Liles/ Denise Brigham

Enrolled: 16
Target Accrual: 45
YTD: 1

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: Liles/Kaitlyn Walker

Enrolled: 15
Target Accrual: 205
YTD: 9

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: Liles/Denise Brigham

Enrolled: 0
Target Accrual: 2
YTD: 0

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: Liles/Denise Brigham

Enrolled: 0
Target Accrual: 3
YTD: 0

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: Walker/Susan Eubanks

Enrolled: 0
Target Accrual: 60
YTD: 0

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: Walker/Susan Eubanks

Enrolled: 0
Target Accrual: 20
YTD: 0

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: Walker/ Susan Eubanks

Enrolled: 0
Target Accrual: 15
YTD: 0

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: Stroud/ Susan Eubanks

Enrolled: 38
Target Accrual: 100
YTD: 0

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: Walker/ Susan Eubanks

Enrolled: 4
Target Accrual: 60
YTD: 0

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: Stroud/ Susan Eubanks

Enrolled: 118
Target Accrual: 357
YTD: 34

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: Stroud/ Susan Eubanks

Enrolled: 289
Target Accrual: 357
YTD: 54

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: Walker/ Kaitlyn Walker

Enrolled: 34
Target Accrual: 100
YTD: 20

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

Disease/Site: Lung
Protocol Number: CLIP-IT
Phase: NA
PI/Coordinator: Yogarajah/ Amanda Wethering

Enrolled: 0
Target Accrual: 30
YTD: 0

Identification of Biomarkers in Lung Cancer Patients Treated with Immunotherapy

Disease/Site: Lung
Protocol Number: Yang
Phase: NA
PI/Coordinator: Stroud/ Susan Eubanks

Enrolled: 3
Target Accrual: 20
YTD: 2

Carolina Senior: UNC Registry For Older Patients

Disease/Site: Cancer Registry
Protocol Number: LCCC0916
Phase: NA
PI/Coordinator: Walker/ Any Available

Enrolled: 60
Target Accrual: 50
YTD: 0

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: Gordon/ Debra Peaden

Enrolled: 5
Target Accrual:
YTD: 1

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: Zervos/ Kaitlyn Walker

Enrolled: 6
Target Accrual: 12
YTD: 0

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: Lepera/ Renee Coghill

Enrolled: 9
Target Accrual: 5
YTD: 0

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: Walker/ Renee Coghill

Enrolled: 2
Target Accrual: 16
YTD: 0

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: Liles/ Amanda W.

Enrolled: 0
Target Accrual: 3
YTD: 0

Thrombotic Thrombocytopenic Purpura (TTP) Registry

Disease/Site: TTP Registry
Protocol Number: TTP Registry
Phase: NA
PI/Coordinator: Liles/ Any Available

Enrolled: 16
Target Accrual: 200
YTD: 0

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: Liles/ Denise Brigham

Enrolled: 1
Target Accrual: 5
YTD: 0

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: Liles/ Denise Brigham

Enrolled: 1
Target Accrual: 5
YTD: 0

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