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Disease Oriented Committees

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  1. DOCS Disease Oriented Committees

  2. Definitions • DOC: disease oriented committees • CW: Cindy Witkowski, R.N. • CCTO: Cancer Clinical Trials Office (formerly CRDM) • RSC: research support center • PRMC: protocol review and monitoring committee • PI: principle investigator

  3. Disease Oriented Committees • Purpose • Idea incubator • Facilitate translational research • Prioritize and manage resources • Structure • Coordinators • Open membership

  4. Idea Incubator • Organized by disease sites • Meeting places and times published • All are welcome • Contact the coordinator when ready to present a concept

  5. Feasibility • Sound idea and design: study will answer a relevant question • Adequate interest • Resource availability • Subjects • Space • Personnel • Funding

  6. Manage Resources • Close trials not meeting accrual • Decide which trials to open • Distribution of tissue from the bank • Help develop policies for publication, determination of principle investigator, distribution of residuals, trips to investigator meetings

  7. Process

  8. Process OverviewClinical Trials Feasibility/interest Scientific merit/design Regulatory compliance/study conduct

  9. Clinical Trial Process

  10. Clinical Trial Process: Investigator Initiated

  11. Clinical Trial Process: Industry

  12. Clinical Trial Process

  13. Execute Trial • Study initiation • Recruitment • Registration • Study procedures • Data collection • Safety reports • Monitoring/audits • Regulatory work

  14. Post Study • Analyze results • Publish results • Plan next study

  15. DOC Coordinator: Anne-Marie Maddox, MD 501-686-8511 Leukemia/Lymphoma DOC

  16. Leukemia/Lymphoma DOCMeeting • When: 3rd Tuesday 4:30-5:30pm • Where: Hospital Pathology Conference Room • Who: Anne-Marie Maddox, MD David Becton, MD

  17. Leukemia/Lymphoma Current clinical protocols • PH II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-CellNon-Hodgkin’sLymphoma • Phase II Study of Lenalidomide (Revlimid®, NSC-703813) For Previously Untreated Non-M3 Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 Or Older Who Decline Remission Induction Chemotherapy • A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND#101261) or Placebo in Newly Diagnosed) Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML)

  18. Leukemia/LymphomaCurrent clinical protocols (cont.) • Cytogenetic Studies in Leukemia Patients • Leukemia Centralized Reference Laboratories and Tissue Repositories – Consent to Perform Cellular and Molecular Studies in Leukemia Pts

  19. Leukemia/LymphomaCurrent clinical protocols ACH • High Risk B-precursor Acute Lymphoblastic Leukemia • Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL) (Initial CR1>/=18 months) • Standard Risk B-Precursor Acute Lymphoblastic Leukemia • Classification of Acute Lymphoblastic Leukemia

  20. Leukemia/LymphomaCurrent clinical protocols ACH (ct.) • Understanding the Ethnic and Racial Differences in Survival in Children with Acute Lymphoblastic Leukemia • Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies • Intensified Methotrexate, Nelarabine (Compound 506U78; IND#52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL)

  21. Leukemia/LymphomaCurrent clinical protocols ACH (ct.) • A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens • A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443 ) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) • Establishing Continuous Cell Lines and xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies

  22. Leukemia/LymphomaCurrent clinical protocols ACH (ct.) • The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years • A Phase III Randomized Trial of GemtuzumabOzogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults • Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia

  23. Leukemia/LymphomaCurrent clinical protocols ACH (ct.) • A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND #58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia • Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome (DS)

  24. Leukemia/LymphomaCurrent clinical protocols ACH (ct.) • Rare and Cutaneous Non-Hodgkin Lymphoma Registry • Hodgkin Disease Banking Study • A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with Newly Diagnosed High Risk Hodgkin Lymphoma

  25. Leukemia/Lymphoma Basic and Translational research • The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia • Pilot Study of DNA Methylation in Myelodysplastic Syndrome and Acute Myeloid Leukemia on UAMS Tissue Bank Frozen Biospecimens

  26. DOC Coordinator: Laura Hutchins, MD 501-686-8511 Brain DOC

  27. Brain DOCMeeting • When: TBD • Where: TBD • Who: Laura Hutchins, MD John Day, MD Maxim Dobretsov, PhD

  28. BrainCurrent clinical protocols • A Phase I, Open Label, Multi-Center Study to Evaluate the Safety and Tolerability of CT-322 Administered in Combination with Focal Brain Radiotherapy and Temozolomide to Subjects with Newly Diagnosed GlioblastomaMultiforme

  29. BrainCurrent clinical protocols ACH • A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens • A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial • A Phase II Study of Conformal Radiotherapy in Patients with Low Grade Gliomas

  30. BrainCurrent clinical protocols ACH (ct.) • Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients • Treatment of Atypical Teratoid/Rhabdoid Tumors of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation • Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

  31. BrainCurrent clinical protocols ACH (ct.) • A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy without Methotrexate • Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

  32. DOC Coordinator: Issam Makhoul, MD 501-686-8511 DOC

  33. GIMSG DOCMeeting • When: 2nd and 4th Wednesdays, 5:00pm • Where: Hem/Onc Classroom, 5th floor Cancer Institute • Who: Brian Badgwell, MD Michael Beheshti, MD Jonathon Laryea, MD Frederick Bentley, MD Issam Makhoul, MD Michael Borrelli, PhD Jose Penagaricano, MD Rang Govindarajan, MD A. Mazen Safar, MD Randy Haun, PhD Eric Siegel, MS Damir Herman,PhD Frank Simmen, PhD

  34. The Missing Piece of the Puzzle

  35. GIMSG DOC • What: • Evaluate the needs of the field • Propose basic and clinical research projects • With a clear vision/strategy and, • After assessment of the local environment to maximize the use of existing resources • Grant submission • Provide mentoring structure for fellows and junior faculty • Presentation of results of research at scientific meetings • Develop an integrated educational program in GIM (Rasco Symposium has been expanded) • Publications

  36. GICurrent clinical protocols • Hepatobiliary cancers • Bevacizumab and erlotinib in metastatic HHC (completed, publication) • A Phase II Trial of Adjuvant Capecitabine / Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in ExtrahepaticCholangiocarcinoma (EHCC) (open) • Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib (GIDEON) (open) • Pancreatic cancer

  37. GICurrent clinical protocols (cont). • Carcinoid tumors • Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients (open) • Gastroesophageal • Colorectal cancer • A pilot study to quantify the variance between numbers of circulating tumor cells (CTCs) from major vein draining the colon tumor, the peripheral venous system, the arterial system in individuals with stage II-III colon cancer who will be undergoing definitive surgical resection (open)

  38. GICurrent clinical protocols ACH • Establishing Continuous Cell Lines and xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies • A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children With Relapsed/Refractory Solid Tumors • Treatment of Children with All Stages of Hepatoblastoma

  39. GIResearch in the Pipeline • Hepatobiliary cancers • Gene expression profiling of HCC in response to glucose or insulin and their role in promoting metastasis (planning) • Progenitor endothelial cell differentiation pattern in response to HCC cell line stimulation (underway) • CTSU E1208, A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in UnresectableHepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion (submitted to IRB) • A Randomized, Double-blind, Multi-center Phase III Study of Brivanib vs. Sorafenib as First-line Tx in Patients with Advanced HCC (The BRISK FL Study) (ready to open)

  40. GIResearch in the Pipeline (cont.) • A Randomized, Double-Blind, Multi-center Phase III Study of Brivanib plus Best Supportive Care (BSC) versus Placebo plus BSC in Subjects with Advanced HCC who have Failed or are Intolerant to Sorafenib: The BRISK PS Study (ready to open) • Comprehensive Liver Cancer Treatment Center

  41. GI Research in the pipeline (cont.) • Pancreatic cancer • Pancreatic stem cells and novel treatment discovery (underway) • A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemotherapy with Radiation therapy for Patients with UnresectableAdenocarcinoma of the Pancreas (submitted to IRB) • Diabetes and pancreatic cancer (underway) • Pilot project of saliva-based genomic markers for pancreatic cancer • Predictors of stage and survival in pancreatic cancer: a population-based analysis from the Arkansas cancer registry

  42. GI Research in the pipeline (cont.) • Colorectal cancer • Evaluation of the factors governing exclusive localization in the liver of certain genotypes of colon cancer (Planning) • Study of neoadjuvantchemoradiation therapy with a novel biologic agent in rectal cancer (Planning) • CTSU ACOSOG Z6051 A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resuction Versus Open Resection for Rectal Cancer (submitted to IRB) • Impact of antidiabetic agents on survival of patients with CRC (completed)

  43. DOC Coordinator: Imran Ahmad, MD 501-686-8511 GU DOC

  44. GU DOCMeeting • When: 1st Tuesday, 5:00pm • Where: Hospital radiology conference room • Who: Imran Ahmad, MD Konstantinos Arnaoutakis, MD Damir Herman, PhD Mohamed Kamel, MD

  45. GUCurrent clinical protocols • CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer • A Rand Double-Blind, Placebo-Controlled Ph III Study of Early Vs Standard Zoledronic Acid to Prevent Skeletal Related Events in Men w/ Prostate Cancer Metastasis to Bone • CTSU CALCG 90203, A Randomized Phase III Study of neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical prostatectomy in Patients with High-Risk, Clinically Localized prostate Cancer

  46. GUCurrent clinical protocols (cont.) • A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma • A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma

  47. GU Current clinical protocols ACH • Renal Tumors Classification, Biology, and Banking Study • Establishing Continuous Cell Lines and xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies • A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children With Relapsed/Refractory Solid Tumors

  48. GU Current clinical protocols ACH (ct.) • Treatment of High Risk Renal Tumors • Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor • Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors • Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

  49. GU Research in the pipeline • CTSU CALGB 90601 A Randomized Doble-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab (IND #7921, NSC #704865) to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma • SWOG 0337 A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer