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UAB CLINICAL TRIALS

By Harry James,2014-06-26 21:40
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UAB CLINICAL TRIALS ...

    University of Alabama at Birmingham

    Comprehensive Cancer Center

    CLINICAL TRIALS

    October/November/December 2009

    ?For Information Call Alma DelGrosso, RN, OCN at 205-934-0337

    Or The Clinical Studies Unit at 205-934-0309

    Disease Category Study Coordinator Phone Number/Pager Number Leukemia/Lymphoma E Jeanne Connor 975-2944/Pager #7803 X Amy Valdmanis 975-9481/Pager #8683 OGI/GU Dayle Craig 975-8080/Pager #5814 H Debbie Gilbert 975-0073/Pager #7506 GLung Anna Messer 934-5092/Pager #2516 G Wilma Dillard 975-9289/Pager #2282 Z Sandra Calloway 975-4437 Z Ashlee Rawlins 996-7361 KBreast Valerie Caterinicchia 934-5367/Pager #5424 R Robyn Wilson 975-6347/Pager #2839 So Joey Richardson 975-0450/Pager #7957 AMelanoma Ronda Carlisle 975-2511/Pager #6093 V Teresa Ross 978-2848/Pager #9412 LD Neurofibromatosis Liz Davis934-5376

    CRTOG & RAD Latania Oldham 975-2880/Pager #1676 BBMT Lisa Williams 934-0066/Pager #8178

    M Radiology Lisa Nelson 934-4015/Pager #6904

    D Head and Neck Surgery Lisa Clemons 934-9714/Pager #7354

    I Gynecology Oncology JoLane Gable 930-8645/Pager #5676 L Regina Bagley 930-8647/Pager #5806 Y Laura Jones 930-8646/Pager #1380 Q Neuro-Oncology Thiru Pillay934-1842/Pager #5205 So Surgical Oncology Joey Richardson975-0450/Pager #7957

    SC = Study Coordinator

    DISEASE CATEGORY PROTOCOL # DESCRIPTION SC

    BREAST

    Neo-Adjuvant UAB 0648 A Phase II, Randomized, Open Label Trial of Pre-Operative R ? (Neoadjuvant) Letrozole (Femara) vs. Letrozole in Combination ?with Avastin in Post-Menopausal Women with Newly Diagnosed

    Operable Breast Cancer (Breast Cancer Research Foundation

    Johns Hopkins Consortium)

    Neo-Adjuvant UAB 0493 Phase II Trial of Primary Systemic Therapy for Locally Advanced R

     Breast Cancer using Sequential Doxil, Paclitaxel, and

    Cyclophosphamide with Concurrent Avastin

    Neo-Adjuvant UAB 0763 A Phase II Trial of Lapatinib in Combination with Trastuzumab K

     with or without Endocrine Therapy for Locally Advanced HER2

    Overexpressing Breast Cancer Patients

    Adjuvant ECOG PACCT-1 Program for the Assessment of Clinical Cancer Tests (PACCT-1): R

    Trial Assigning Individualized Options for Treatment: The

    TAILORx Trial

    Adjuvant IBCSG 24-02 A Phase III Trial Evaluating the Role of Ovarian Function K

    Suppression and the Role of Exemestane Adjuvant Therapies for

    Premenopausal Women with Endocrine Responsive Breast Cancer Adjuvant S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for K

    Primary Breast Cancer

    Adjuvant E5103 A Double-Blind Phase III Trial of Doxorubicin and K

    Cyclophosphamide followed by Paclitaxel with Bevacizumab or

    Placebo in Patients with Lymph Node Positive and High Risk

    Lymph Node Negative Breast Cancer

    Adjuvant UAB 0813 A Multicenter Phase III Randomized Trial of Adjuvant Therapy K

    for Patients with HER2-Positive Node-Positive or High Risk

    Node-Negative Breast Cancer Comparing Chemotherapy Plus

    Trastuzumab with Chemotherapy Plus Trastuzumab Plus

    Bevacizumab (BETH Study) stMetastatic 1A Randomized, Multicenter, Phase II Study of the Efficacy and Safety of Line UAB 0836 K Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin?) and Docetaxel

    (Taxotere?) in Patients with Metastatic HER2-Positive Breast Cancer

    Who Have Not Received Prior Chemotherapy for Metastatic Disease Metastatic UAB 0762 A Phase 2 Study of Lapatinib in Combination with Trastuzumab R

    in Patients with HER2-Positive, Metastatic Breast Cancer Metastatic UAB 0761 DNA Methylation in Serum as a Predictive Marker of Progression R

     and Survival Following Systemic Therapy in Patients with

    Metastatic Breast Cancer

    Metastatic UAB 0778 MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-R

    Angiogenic Therapy in Postmenopausal Patients with Hormone

    Receptor Negative Breast Cancer. A Translational Breast Cancer

    Research Consortium (TBCRC) Trial

    Metastatic UAB 0905 A Phase I/II Study inR1507 with Letrozole for Postmenopausal R

    Women with ER+ HER2-Advanced Breast Cancer

     RTOG 0413 A Randomized, Phase III Study of Conventional Whole Breast C

    Irradiation vs. Partial Breast Irradiation for Women with Stage 0,

    I, or II Breast Cancer ndMetastatic 2 Line UAB 0909 A Phase II Study of Cisplatin or Carboplatin for Triple-Negative K

    Metastatic Breast Cancer and Evaluation of p63/p73 as a

    Biomarker of Response

    Preventive UAB 0413 A Phase III Randomized Study of Exemestane vs. Placebo in SO

    Postmenopausal Women at Increased Risk of Developing Breast

    Cancer

    SC = Study Coordinator

    DISEASE CATEGORY PROTOCOL # DESCRIPTION SC GASTROINTESTINAL

    Colorectal ECOG 5202 A Randomized Phase III Study Comparing 5-FU, Leucovorin and A

    Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and

    Bevacizumab in Patients with Stage II Colon Cancer at High Risk

    for Recurrence to Determine Prospectively the Prognostic Value

    of Molecular Markers

    Pancreatic UAB 0601 A Phase 2 Double-Blind, Placebo Controlled, Multi-center O

    Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-

    4000; an Inactivated Recombinant Saccharomyces cerevisiae

    Expressing Mutant Ras Protein Combined with a Gemcitabine

    Regimen Versus a Gemcitabine Regimen with Placebo, in Patients

    with Post-resection R0/R1 Pancreatic Cancer with Tumor

    Sequence Confirmation of Ras Mutations

    Pancreatic UAB 0914 A Randomized Phase III Study of Weekly ABI-007 plus O

    Gemcitabine versus Gemcitabine Alone in Patients with

    Metastatic Adenocarcinoma of the Pancreas

    Pancreatic Neo-Adjuvant UAB 0808 A Phase II Study of Short-Course Preoperative Erlotinib followed SO

    by Post-Resection Erlotinib-Gemcitabine in Patients with

    Resectable Pancreatic Adenocarcinoma

    Liver UAB 0844 A Phase III randomized, double-blind, placebo-controlled study of O

    sorafenib as adjuvant treatment for hepatocellular carcinoma after

    surgical resection or local ablation

    Liver RAD 0901 Stereotactic Radiation Therapy and Sorafenib in the Treatment of C

    Hepatocellular Carcinoma

    Esophageal RTOG 0436 A Phase III Trial Evaluating the Addition of Cetuximab to C

    Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal

    Cancer who are Treated Without Surgery

    RADIATION ONCOLOGY

    R08-012 Physiologic Magnetic Resonance Imaging of Pancreatic Tumors M at 3%

    F08-030 Phase III Randomized Trial of Cryoablation vs. Radiation for the M Palliation of Painful Bone Metastases

    RTOG 0517 Randomized Phase III Trial to Evaluate Radio-pharmaceuticals C and Zoledronic Acid in the Palliation of Osteoblastic Metastases

    from Lung, Breast and Prostate Cancer

    RAD 0408 Phase II Study of Spinal Radiosurgery C

    BMT

    Allogeneic PBSC Transplant UAB 0624 Standardization of CD3+ T-Cell Dose for Patients Receiving B Patients Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplants

    from Matched Related Donors

    ALL, AML, MDS UAB 0462 Phase 3 Multicenter study Comparing G-CSF Mobilized PBSC v. B Having an unrelated donor HSCT Marrow for MUD HSCT.

    Low Grade B Cell Malignancies UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic B

    Cell Transplantation Protocol From HLA Matched Donors for the

    Treatment of Patients with Low Grade B Cell Malignancies. New Onset Acute GvHD UAB 0777 Phase III, Randomized, Double-Blind,Placebo-Controlled Study B

    to Evaluate the Efficacy and Safety of Prochymal (Ex-vivo

    Cultured Adult Human Mesenchymal Stem Cells) Infusion in

    Combination with Corticosteroids for the Treatment of Newly

    Diagnosed Acute GvHD

    SC = Study Coordinator

    DISEASE CATEGORY PROTOCOL # DESCRIPTION SC GENITOURINARY

    Prostate RTOG 0534 Phase III Trial of Short Term Androgen Deprivation with Pelvic C

    Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in

    Prostate Cancer Patients with a Rising PSA after Radical

    Prostatectomy

    Kidney E2804 The BeST Trial: A Randomized Phase II Study of VEGF, RAF A

    kinase, and mTOR Combination Targeted Therapy (CTT) with

    Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal

    Cell Carcinoma

    Renal Cell ECOG 2805 A Randomized, Double-blind Phase III Trial of Adjuvant A

    Sunitinib versus Sorafenib versus Placebo in Patients with

    Resected Renal Cell Carcinoma

    HEAD AND NECK

    Head and Neck RAD 0503 Phase II Trial of Erlotinib and Radiotherapy in Patients with Stage C

    III Cutaneous Squamous Cell Carcinoma

    Head & Neck Specimen Bank RTOG 0514 Establishment of a Head and Neck Cancer Tissue Specimen Bank C Head and Neck Surgery UAB 0718 Phase II Trial to Assess Target Oral Therapy as Adjuvant D

    Chemoprevention in High-Risk Head & Neck Cancer Head and Neck RTOB 0619 Randomized Phase II Trial of Chemoradiotherapy vs. Chemo-C

    radiotherapy and Vandetanib for High Risk Post-Operative

    Advanced Squamous Cell Carcinoma of the Head and Neck Oral Cavity, Oropharynx, UAB 0749 Phase II, Open Label, Single Arm Trial to Investigate D Hypophrynx or Larynx Zulutumumab in Combination with Best Supportive Care in Non-

    Curable Patients with Recurrent and/or Metastatic Disease who

    have Failed at Least One Course of Standard-Based

    Chemotherapy

    Thyroid UAB 0835 An International, Randomized, Double-Blinded, Phase 3 Efficacy A

    Study of XL184 versus Placebo in Subjects with Unresectable,

    Locally Advanced, or Metastatic Medullary Thyroid Cancer LEUKEMIA

    Acute Leukemias, CML, UAB 0657 A Phase I/IIa Open-label Study to Assess the Safety, Tolerability X

    MDS, MMM and Preliminary Efficacy of AT9283, a Small Molecule Inhibitor

    of Aurora Kinases, in Patients with Acute Leukemias, Chronic

    Myeloid Leukemia, High-Risk Myelodysplastic Syndromes or

    Myelofibrosis

    AML CALGB 10603 A Phase III Randomized, Double-Blind Study of Induction X

    (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)

    AML UAB 0916 An Open-Label, Dose-Escalation, Phase I/II Study to Investigate E

    the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical

    Activity of the MEK Inhibitor GSK1120212 in Subjects with

    Relapsed or Refractory Leukemias

    AML/MDS UAB 0822 A Randomized Phase II Study of Oral Sapacitabine in Elderly X

    Patients with Acute Myeloid Leukemia Previously Untreated or in

    First Relapse, or Previously Treated Myelpdysplastic Syndrome SC = Study Coordinator

null

    DISEASE CATEGORY PROTOCOL DESCRIPTION SC

    LYMPHOMA

    Diffuse Large B Cell UAB 0758 A Randomized Phase IIb Placebo-controlled Study of R-ICE X Lymphoma Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and

    Etoposide) with and without SGN-40 (anti-CD40 humanized

    monoclonal antibody) for Second-line Treatment of Patients with

    Diffuse Large B-Cell Lymphoma

     UAB 0759 A Phase Ib Study of SGN-40 (anti-huCD40 mAb) in E

    Combination with Rituximab and Gemcitabine for the Treatment

    of Patients with Relapsed or Refractory Diffuse Large B-Cell

    Lymphoma

     UAB 0920 A Phase 2 Study of Inotuzumab Ozogamicin (CMC-544) in X

    Subjects With Indolent Non-Hodgkin’s Lymphoma (NHL) That

    is Refractory to or has Relapsed After Rituximab and

    Chemotherapy or Radioimmunotherapy

     UAB 0924 Phase 2: Retreatment with SGN-35 in Patients with CD30-E

    Positive Hematologic Malignancies

    Anaplastic UAB 0853 A Pivotal Study of SGN-35 in Treatment of Patients with E

    Relapsed or Refractory Anaplastic Large Cell Lymphoma

     UAB 0663 Phase II, Open-Label Investigation of Lenalidomide (Revlimid?) X

    Therapy for Patients with Relapsed and/or Refractory Peripheral

    T-Cell Lymphomas

     UAB 0745 Single Agent, Phase II Study of Forodesine (BCX1777) in the E

    Treatment of Cutaneous T-Cell Lymphoma

     UAB 0757 An Open-Label, Phase Ib Study of the Safety, Pharmacokinetics E

    and Activity of the Anti-CD40 Monoclonal Antibody SGN-40

    Administered in Combination with Rituximab in Patients with

    CD20-Positive Follicular and Marginal Zone B-Cell Non-

    Hodgkin’s Lymphoma Who Have Relapsed Following Previous

    Rituximab

     UAB 0769 A Phase I dose escalation study of weekly SGN-35 alone and in E

    combination with Gemcitabine in patients with

    relapsed/refractory CD-30 positive malignancies

     UAB 0830 A Phase I/II Study of TRU-016 in Patients with Previously X

    Treated Chronic Lymphocytic Leukemia

     UAB 0824 Phase I/II Study of Immunotherapy with Milatuzumab (hLL1) in E

    Patients with Non-Hodgkin’s Lymphoma (NHL) and Chronic

    Lymphocytic Leukemia (CLL)

    SC = Study Coordinator

    DISEASE CATEGORY PROTOCOL DESCRIPTION SC

    MELANOMA

    UAB 0922 An Open-Label, Multicenter, Phase III Trial of ABI-007 vs. V

    Dacarbazine in Previously Untreated Patients with Metastatic

    Malignant Melanoma

    UAB 0904 A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study V

    Evaluating the Efficacy of ABT-888 in Combination with

    Temozolomide vs. Temozolomide Alone in Subjects with

    Metastatic Melanoma

    UAB 0829 A Double-Blind, Randomized, Placebo-Controlled, Phase II V

    Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as

    Adjuvant Therapy in Patients with MAGE-A3 Positive Resected

    Stage III Melanoma

    ECOG 2602 Phase II Study of Low Dose Peginterferon Alfa-2b in Patients V

    with Metastatic Melanoma Over-Expressing Basic Fibroblast

    Growth Factor

    E1697 Phase III Randomized Study of Four Weeks High Dose IFN ? -V

    2b in Stage T T or N(microscopic) Melanoma 341

    MYELOMA

     UAB 0823 A Phase 1 Safety Study of LY2127399 in Combination with X

    Bortezomib in Patients with Relapsed or Refractory Multiple

    Myeloma

     UAB 0845 A Phase III, Randomized, Open-Label, 3-Arm Study to X

    Determine the Efficacy and Safety of Lenalidomide (Revlimid)

    Plus Low-Dose Dexamethasone When Given Until Progressive

    Disease or for 18 Four-Week Cycles Versus the Combination of

    Melphalan, Prednisone, and Thalidomide Given for 12 Six-Week

    Cycles in Patients with Previously Untreated Multiple Myeloma

    Who Are Either 65 Years of Age or Older or Not Candidates for

    Stem Cell Transplantation

    NEUROFIBROMATOSIS

     X071214010 A Phase II Study of the mTOR Inhibitor, Sirolimus, in LD

    Neurofibromatosis Type I Plexiform Neurofibromas

     X080929007 A Randomized Placebo-Controlled Study of Lovastatin? in LD

    Children with Neurofibromatosis Type I

    SARCOMA

    UAB 0850 A Randomized, Double-Blind, Phase III Study of Pazopanib vs. V Placebo in Patients with Soft Tissue Sarcoma Whose Disease has

    Progressed During or Following Therapy

    UAB 0814 A Pivotal Trial to Determine the Efficacy and Safety of AP23573 V when Administered as Maintenance Therapy to Patients with

    Metastatic Soft-Tissue or Bone Sarcomas

    SOLID TUMORS

    UAB 0444 A Treatment Protocol for Patients Continuing from a Prior G SU011248 Protocol

    UAB 0827 Phase III Randomized Trial of Cryoblation vs. Radiation for the M Palliation of Painful Bone Metastases

    SC = Study Coordinator

    DISEASE CATEGORY PROTOCOL DESCRIPTION SC

    NEURO ONCOLOGY

     NABTT 0603 Phase I/II Trial of Hydroxychloroquine in Conjunction with Q

    Radiation Therapy and Concurrent and Adjuvant Temozolomide

    in Patients with Newly Diagnosed Glioblastoma Multiforme

     NABTT 0504 A Feasibility Assessment and a Phase I/II Trial of MLN518 for Q

    Treatment of Patients with Recurrent Glioblastoma

     UAB 0752 Phase I Dose Escalation Study Evaluating the Safety and Q

    Biologically Active Dose of TM-601 Based on Perfusion MR

    Imaging Criteria in Patients with Progressive and/or Recurrent

    Malignant Glioma

     UAB 0832 Phase I/II Trial of BIBW 2992 with or without Temodar in the Q

    Treatment of Patients with Recurrent GMM

     UAB 0766 Phase III Randomized, Parallel Group, Multi-Center Study in Q

    Recurrent Glioblastoma Patients to compare the Efficacy of

    Cediranib Recentin, A2D2171 Monotherapy with the

    Combination of Cediranib with Lomustine to the Efficacy of

    Lomustine Alone

     NABTT 0703 Phase I/II Trial of BSI-201 in the Treatment of Patients with Q

    Newly Diagnosed GBM

    GYNECOLOGY ONCOLOGY

    Ovarian GOG 212 A Randomized Phase III Trial of Maintenance Chemotherapy L

    Comparing 12, Monthly Cycles of Single Agent Paclitaxel or

    Xyota vs. No Treatment until Documented Relapse in Women

    with Advanced Ovarian or Primary Peritoneal Cancer who

    Achieve a Complete Clinical Response to Primary

    Platinum/Taxane Chemotherapy

     UAB 0802 Death Receptor-Medicated Apoptosis Study to Collect Tissue I

    Samples and Information from Ovarian Cancer Patients

     UAB 727 A Phase II Protocol of Carboplatin/Gemcitabine + Bevacizumab I

    vs. Placebo

     UAB 0821 Phase I Study of Ad5.SSTR/TK.RGD: A Tropism modified I

    Adenovirus Vector for IP Delivery of Therapeutic Genes and

    Additional Capability of Noninvasive Imaging of Gene Transfer

    in Patients with Recurrent Ovarian and Other Selected

    Gynecologic Cancers

     UAB 0906 Phase II Study of CS-1008 in Combination with Chemotherapy I

    (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic

    Ovarian Cancer

     UAB 604 A Phase II Study of Paclitaxel & Carboplatin in Patients with an Y

    Elevated Risk Adenocarcinoma of the Endometrium Cervical Therapeutic GOG 0240 A Randomized Phase III Trial of Cisplatin + Paclitaxel with and Y

    without NCI-Supplied Bevacizumab vs. the Non-Platinum

    Doublet, Topotecan + Paclitaxel, with and without NCI-Supplied

    Bevacizumab, in Stage IVB Recurrent or Persistent Carcinoma of

    the Cervix

    SC = Study Coordinator

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