Phase 3 And Phase 4 Clinical Trials
Phase 3 And Phase 4 Clinical Trials' title='Phase 3 And Phase 4 Clinical Trials' />Clinical Trials St. Jude Childrens Research Hospital. A Phase I Study of MK 1. IND1. 16. 45. 9 Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas. Diseases Treated Newly diagnosed Diffuse Intrinsic Pontine Glioma DIPGEligibility Participant is 3. Participant has newly diagnosed DIPG. Participant has a brainstem tumor that was biopsied and proven to be one of the following anaplastic astrocytoma, glioblastoma, gliosarcoma, or anaplastic mixed glioma. Participant has not received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG. Prior dexamethasone andor surgery are allowed. View Trial. A Phase III Study of MK 1. AZD1. 77. 5, IND 1. Combination with Oral Irinotecan In Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors. Diseases Treated Relapsed or refractory solid tumors. Chapter 3. 3 Interventions and therapies, including clinical and nonclinical trials, and innovations. BristolMyers Squibb and Clovis Oncology Announce a Broad Clinical Collaboration to Evaluate Combination of Opdivo Nivolumab and Rubraca Rucaparib in Phase 2. Methods. In two randomized, placebocontrolled, phase 3 trials of identical design SOLO 1 and SOLO 2, we enrolled adults with moderatetosevere atopic dermatitis. A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials. Eligibility Participant is 1. Participant has had histologic verification of malignancy at original diagnosis or relapse. Participant has serum tumor markers including alpha fetoprotein or beta HCG. Participant has a relapsed or refractory solid tumor. View Trial. A Phase I Study of Selinexor KPT 3. IND 1. 25. 05. 2, a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors. Diseases Treated Solid Tumors. Eligibility Diagnosis of solid tumor that is resistant to other anticancer therapy or has come back after therapy. Includes lymphoma and central nervous system CNS tumors that may or may not require surgery. Fully recovered from the acute toxic effects of all prior anticancer therapy. At least 1 but not more than 2. Able to swallow tablets whole. View Trial. A Phase I Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor 2 VEGFR 2 Receptor in Children with Refractory Solid Tumors, Including CNS Tumors. Diseases Treated Brain Tumors. Solid Tumors. Eligibility 1. Diagnosis Part A Non central nervous system CNS tumor that returned after treatment or did not respond to treatment. Part B CNS tumor that returned after treatment or did not respond to treatment. No other proven therapy options. View Trial. A Phase I Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma. Diseases Treated Solid Tumor, CNS Tumor, Lymphoma. Eligibility 1. 2 months to 2. Able to swallow whole tablets. Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma. Figure%208.png' alt='Phase 3 And Phase 4 Clinical Trials' title='Phase 3 And Phase 4 Clinical Trials' />View Trial. A Phase I Study of LY2. A CHK12 Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors Diseases Treated Solid Tumor, CNS Tumor. Eligibility 1. 2 months to 2. Diagnosis of recurrent or refractory solid tumor, including CNS tumor. View Trial. A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B Cell Acute Lymphoblastic Leukemia and Lymphoma. Diseases Treated Relapsed or refractory precursor B cell acute lymphoblastic leukemia and lymphoma. Eligibility B cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has. Come back after treatment the first time. Did not respond to treatment the first time. Less than 2. 2 years of age. Does not have HIV or hepatitis B infection. Summary. Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. A common example of this. Clinical Trials for LDN. Updated May 3, 2013. In Brief Recently Published Clinical Trials Clinical Trials in Progress Animal Trials Past Completed Clinical Trials. View Trial. A Phase II Study of Human Mouse Chimeric Anti Disialoganglioside Monoclonal Antibody ch. Dinutuximab in Combination with Sargramostim GM CSF in Patients with Recurrent Osteosarcoma. Diseases Treated Osteosarcoma. Eligibility Younger than 3. Original diagnosis of osteosarcoma. Osteosarcoma has come back in the lungs after original treatment. Lung tumors have been removed surgically within the last 4 weeks before enrolling in the study. View Trial. A Phase I Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD1. Positively Selected Autologous Hematopoietic Stem Cells In Children With High Risk Solid Tumors or Lymphomas. Diseases Treated High risk solid tumors and lymphomas. Eligibility Has a type of high risk cancer including. Neuroblastoma. Solid tumors. Lymphomas. 21 years of age or younger. Has not received a prior hematopoietic blood cells from bone marrow stem cell transplant within the previous three months. View Trial. A Phase I Study of Talazoparib BMN 6. Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies. Diseases Treated Relapsed or refractory solid tumors. Eligibility Participant has refractory or recurrent solid tumor for which there is no standard therapy. Participant has had histologic verification of malignancy at original diagnosis or at the time of relapse. Participant is twelve 1. Participant life expectancy is at least eight 8 weeks. View Trial. Phase IIIa, 2 Part, Multi Center, Single Arm, Open Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advance BRAF V6. Mutation Positive Solid Tumors. Diseases Treated Solid tumors, giomas, hystiocytosis. Eligibility Participant is greater or equal to 1. Participant has BRAF V6. CLIA approved laboratory or equivalent. Participant has recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease, OR participant has metastatic or surgically unresectable melanoma, and is being enrolled for first line treatment. Melanoma participants with CNS involvement may be enrolled. View Trial. A Phase II Placebo Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor SCUSF 0. ACCL0. 92. 2. Diseases Treated Brain Tumor Previously treated brain tumors. Eligibility Age is 6 years and lt 1. Off treatment and progressionfree for at least 1. Diagnosis of a primary brain tumor treated with at least one of the following. Neurosurgical resection of the brain tumor Cranial irradiation Any chemotherapy to treat the brain tumor. View Trial. Phase II Trial of Response Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors CNS GCT. Diseases Treated Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma. Eligibility Participant is 3 years and lt 2. Participant has newly diagnosed localized primary NGGCT or newly diagnosed localized germinoma has not spread to other parts of the brain or spine. Participant must have adequate bone marrow function. Participant must have normal renal and liver function for age. NO prior therapy except surgery andor steroids. View Trial. Quadrivalent Human Papillomavirus q. HPV Vaccine in Cancer Survivors Cross Sectional Survey and Phase II Open Label Vaccine Trial A Consortium for Pediatric Interventional Research. Diseases Treated Human papillomavirus. Eligibility This is a non therapeutic clinical trial that is only open to St. Jude patients. Questionnaire phase. Cancer survivor 9 to 2. English or Spanish speaking. Vaccine Phase. Survey response indicated no prior history of HPV vaccination. Agrees to return to participating institution for 3 HPV vaccine injections. Allergy to any component of the HPV vaccine including yeast and aluminum will not be eligible for the study. Research Toward a Cure Trials. A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials. Click the trial registry identifier numbers for a link to the full clinicaltrials. Its important to appreciate that at the current time, none of these studies is expected to produce a cure for HIV infectionthey represent research working toward that goal. Table 3 contains completed studies, with links to published or presented results where available. Changes from the previous update are highlighted in yellow. Additional information on current approaches in HIV cure research can be found in TAGs annual pipeline report and cure research fact sheet. Please send updates, corrections, or suggestions to Richard Jefferys at richard. November 1. 0, 2. Table 1. Current Clinical Trials. Trial. Trial Registry IdentifiersManufacturerSponsorsPhase. Estimated Study Completion Date. ADOPTIVE IMMUNOTHERAPYReconstitution of HIV specific immunity against HIVNCT0. Guangzhou 8th Peoples Hospital. Phase IIIDecember 2. HXTC HIV 1 antigen expanded specific T cell therapy. NCT0. 22. 08. 16. University of North Carolina, Chapel Hill. Phase IDecember 2. ANTIBODIESvedolizumab anti integrin antibodyNCT0. Ottawa Hospital Research Institute. Phase IIDecember 2. VRC0. 1 in acute HIV infection. NCT0. 30. 36. 70. Nittaya Phanuphak, MD, Ph. DPhase IIJune 2. 01. BNC1. 17 broadly neutralizing monoclonal antibodyNCT0. Rockefeller University. Phase IIIMarch 2. BNC1. 17. NCT0. 25. Rockefeller University. Phase IIIMarch 2. VRC0. 1 in infants. Road To Mandalay'>Road To Mandalay. NCT0. 32. 08. 23. NIAIDPhase IIIJanuary 2. NCT0. 25. 11. 99. Rockefeller University. Phase IDecember 2. BNC1. 17 LSNCT0. Rockefeller University. Phase IOctober 2. BNC1. 17 1. 0 1. NCT0. Rockefeller University. Phase I June 2. 01. PGDM1. 40. 0 PGT1. NCT0. 32. 05. 91. International AIDS Vaccine Initiative. Phase IJuly 2. 01. PGT1. 21. NCT0. 29. International AIDS Vaccine Initiative. Phase IMarch 2. 01. NCT0. 27. 88. 17. NIAID Phase IMay 2. VRC0. 1LS long acting broadly neutralizing monoclonal antibodyNCT0. NIAIDPhase IAugust 2. VRC0. 1 in acute HIV infection. NCT0. 25. 91. 42. NIAIDPhase IApril 2. ANTI FIBROTIClosartan. NCT0. 18. 52. 94. University of Minnesota. Phase IIJuly 2. 01. NCT0. 21. 70. 24. Yale University. Phase IFebruary 2. ANTI INFLAMMATORYcanakinumab IL 1 inhibitorNCT0. University of California, San Francisco. Phase IIJune 2. 01. ANTI PROLIFERATIVEmycophenolate mofetil MMFNCT0. Fred Hutchinson Cancer Research Center. Phase IAugust 2. 02. ANTIRETROVIRAL THERAPYdolutegravir in reservoirs. NCT0. 29. 24. 38. Emory University. Phase NAJune 2. 02. ABX4. 64. NCT0. 29. Abivax S. A. Phase IIIMarch 2. COMBINATIONS maraviroc, dolutegravir, dendritic cell vaccine, auranofin, nicotinamide. NCT0. 29. 61. 82. Federal University of So Paulo. Not listed. March 2. Perturbing of HIV reservoir with immune stimulation Fluarix, Pneumovax vaccines. NCT0. 27. 07. 69. University of California, San Diego. Not listed. January 2. Impact of Sirolimus and maraviroc on CCR5 expression and the HIV 1 reservoir in HIV kidney transplant recipients. NCT0. 29. 90. 31. University of Maryland. Phase IVJuly 2. 02. ROADMAP romidepsin 3. BNC1. 17. NCT0. 28. Rockefeller University. Phase IIa. December 2. CLEAR romidepsin 3. BNC1. 17. NCT0. 30. Aarhus University Hospital. Phase IIAugust 2. NCT0. 24. 71. 43. Massachusetts General Hospital. Phase IIFebruary 2. Research In Viral Eradication of HIV Reservoirs RIVER ART, Ch. Ad. V6. 3. HIVconsv MVA. HIVconsv vaccines, vorinostat. NCT0. 23. 36. 07. UK CPMS1. 80. 10closed to enrollmentImperial College London. Phase IIJuly 2. 01. NCT0. 31. 98. 55. The Peter Doherty Institute for Infection and Immunity. Phase IIIJuly 2. SB 7. R T autologous CD4 T cells genetically modified at the CCR5 gene cyclophosphamide. NCT0. 22. 25. 66. Sangamo Bio. Sciences. Phase IIIJune 2. AGS 0. NCT0. 27. 07. 90. NIAIDPhase IDecember 2. CD4 ZETA gene modified T cells interleukin 2 IL 2NCT0. University of Pennsylvania. Phase IJuly 2. 02. DCV3 dendritic cell based vaccine pulsed with autologous inactivated HIV pegylated interferon. NCT0. 27. 67. 19. Judit Pich Martnez, Fundaci Clnic per la Recerca Biomdica Phase IJune 2. MVA. HIVconsv romidepsin. NCT0. 26. 16. 87. Irsi. Caixa. Phase IOctober 2. SB 7. 28m. R T cyclophosphamide. NCT0. 23. 88. 59. University of Pennsylvania. Phase IDecember 2. HXTC HIV 1 antigen expanded specific T cell therapy. NCT0. 32. 12. 98. Julia Sung, MD, University of North Carolina, Chapel Hill. Phase IJune 2. 02. CYTOKINESinterleukin 2 IL2NCT0. Case Western Reserve University Phase IIDecember 2. GENE THERAPIESCal 1 Dual anti HIV gene transfer construct. NCT0. 17. 34. 85. NCT0. 23. 90. 29. Calimmune. Phase IIIOctober 2. January 2. 03. 2VRX4. CD4 T cellsNCT0. University of Pennsylvania. Phase IIIDecember 2. Chimeric Antigen Receptor CAR T cell therapy. NCT0. 32. 40. 32. Guangzhou 8th Peoples Hospital. Phase IDecember 2. SB 7. 28m. R HSPC autologous hematopoietic stemprogenitor cells genetically modified at the CCR5 geneNCT0. City of Hope Medical Center. Phase IJuly 2. 01. Maz. F T redirected Maz. F CD4 autologous T cellsNCT0. Takara BioUniversity of Pennsylvania. Phase IDecember 2. C3. 4 CXCR4 autologous CD4 T cells gene modified to express HIV inhibiting C3. NCT0. 30. 20. 52. University of Pennsylvania. Phase I January 2. GENE THERAPIES FOR HIV POSITIVE PEOPLE WITH CANCERSStem cells gene modified with CCR5 sh. RNATRIM5alphaTAR decoy. NCT0. 27. 97. 47. AIDS Malignancy Consortium. Phase IIISeptember 2. Stem cells gene modified with C4. CCR5P1. 40. KNCT0. Fred Hutchinson Cancer Research Center. Phase IAugust 2. 02. Stem cells gene modified with Cal 1. Aurora 3D Text Logo Maker on this page. NCT0. 23. 78. 92. Fred Hutchinson Cancer Research Center. Phase IJune 2. 01. CRISPR CCR5 modified CD3. NCT0. 31. 64. 13. Hospital of PLA Affiliated Hospital of Academy to Military Medical SciencesNot listed. May 2. 0, 2. 02. 1Stem cells gene modified to encode multiple anti HIV RNAs r. HIV7 sh. I TAR CCR5. RZNCT0. 23. 37. 98. City of Hope Medical Center. Not listed. June 2. Stem cells gene modified to encode multiple anti HIV RNAs r. HIV7 sh. I TAR CCR5. RZ busulfan. NCT0. What Is The Filthy Few Patch For. City of Hope Medical Center. Not listed. October 2. Stem cells gene modified to encode multiple anti HIV RNAs r. HIV7 sh. I TAR CCR5. RZNCT0. 05. 69. 98. City of Hope Medical Center. Not listed. July 2. HORMONESsomatotropin human growth hormoneNCT0. Mc. Gill University Health Center. Phase IIJune 2. 01. IMAGING STUDIESRadiolabeled broadly neutralizing anti HIV antibody 3. BNC1. 17 Copper 6. MRIPET scanning to detect HIV in vivo. NCT0. 30. 63. 78. Bayside Health. Phase IDecember 2. IMMUNE CHECKPOINT INHIBITORSdurvalumab anti PD L1 antibodyin solid tumors. NCT0. 30. 94. 28. Spanish Lung Cancer Group. Phase IIApril 2. 02. PD 1 antibody ipilimumab ant CTLA 4 antibodyin treating patients with advanced HIV associated solid tumors. NCT0. 24. 08. 86. National Cancer Institute NCIPhase IDecember 2. PD 1 antibodyin treating patients with HIV and relapsed, refractory, or disseminated malignant neoplasms. NCT0. 25. 95. 86. National Cancer Institute NCIPhase IApril 2. PD 1 antibody single dose. NCT0. 32. 39. 89. National Institute of Neurological Disorders and Stroke NINDS Phase IDecember 2. JANUS KINASE INHIBITORSruxolitinib. NCT0. 24. 75. 65.