Efficacy and Safety of Sirolimus to Vascular Anomalies
SponsorWest China Hospital
Primary outcomeVolumetric changes in complicated vascular anomalies to sirolimus
Vascular Anomaly
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Primary outcomeAssociation Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC
AML
Impacts of Mechanistic Target of Rapamycin (mTOR) Inhibition on Aged Human Muscle (Rapamune)
SponsorUniversity of Nottingham
Primary outcomeChange in muscle mass from baseline
Muscle AtrophyAge-Related Sarcopenia
Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma
SponsorSt. Joseph's Healthcare Hamilton
Primary outcomeThe rate of change in response of primary tumor and metastases (if applicable)in participants.
Renal Cell Carcinoma
Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence
SponsorHospital do Rim e Hipertensão
Primary outcomeCytomegalovirus infection/disease recurrence
Cytomegalovirus Infections
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Primary outcomeIncidence of Efficacy Failure
Inflammation
Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
SponsorDana-Farber Cancer Institute
Primary outcomeBest Overall Response Rate (BORR)
Cutaneous Squamous Cell CarcinomaSkin Cancer
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
SponsorUniversity Hospital of Berlin
Primary outcomeProgression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors
Renal Transplant Patients at High-risk for Skin Cancer
Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
Primary outcomeAngiomyolipoma volume
Angiomyolipoma
Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
SponsorUniversity of Cincinnati
Primary outcomeComposite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.
Primary Renal Allograft
Efficacy of Rapamycin (Sirolimus) in the Treatment of Peutz-Jeghers Syndrome
SponsorPeking Union Medical College Hospital
Primary outcomeTotal load of PJS-related intestinal polyps Total load of PJS-related intestinal polyps Total load of PJS-related intestinal polyps
Peutz-Jeghers Syndrome
Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors
SponsorSamsung Medical Center
Primary outcomeProgression Free survival
Refractory Solid Tumors
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Primary outcomeProgression-Free Survival (PFS): Independent-Assessment
Renal Cell Carcinoma
Study Evaluating Sirolimus in Kidney Transplant Recipients.
SponsorWyeth is now a wholly owned subsidiary of Pfizer
Primary outcomeTo evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
Kidney FailureGraft vs Host Disease
Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus
SponsorChinese SLE Treatment And Research Group
Primary outcomeThe Proportion of Patients Who Achieve an SLE Responder Index-4 (SRI-4) Composite Response at Week 24
Systemic Lupus Erythematosus
Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin)
SponsorMelanoma and Skin Cancer Trials Limited
Primary outcomeKC development
Solid Organ Transplant RecipientsSkin Cancer
Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation
SponsorSouthern Medical University, China
Primary outcomeHCC recurrence free survival
Liver Transplantation
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome
Primary outcomeChange in Cognitive Function as Assessed by the National Institute of Health (NIH) Toolbox Cognitive Battery
Sturge-Weber Syndrome
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
SponsorAmerican Society of Clinical Oncology
Primary outcomeObjective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
Lymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors
Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
SponsorNational Cancer Institute (NCI)
Primary outcomeProgression Free Survival Rate
Adult Hepatocellular CarcinomaAdvanced Adult Hepatocellular CarcinomaEndometrial Serous AdenocarcinomaLocalized Non-Resectable Adult Liver CarcinomaLung Carcinoid TumorMalignant Pancreatic GastrinomaMalignant Pancreatic GlucagonomaMalignant Pancreatic InsulinomaMalignant Pancreatic SomatostatinomaMetastatic Digestive System Neuroendocrine Tumor G1Ovarian CarcinosarcomaOvarian Endometrioid AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous Surface Papillary AdenocarcinomaPancreatic Alpha Cell AdenomaPancreatic Beta Cell AdenomaPancreatic Delta Cell AdenomaPancreatic G-Cell AdenomaPancreatic Polypeptide TumorRecurrent Adult Liver CarcinomaRecurrent Digestive System Neuroendocrine Tumor G1Recurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Pancreatic Neuroendocrine CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Uterine Corpus CarcinomaRegional Digestive System Neuroendocrine Tumor G1Stage IIIA Fallopian Tube CancerStage IIIA Ovarian CancerStage IIIA Primary Peritoneal CancerStage IIIA Uterine Corpus CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian CancerStage IIIB Primary Peritoneal CancerStage IIIB Uterine Corpus CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian CancerStage IIIC Primary Peritoneal CancerStage IIIC Uterine Corpus CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Primary Peritoneal CancerStage IVA Uterine Corpus CancerStage IVB Uterine Corpus CancerUterine Carcinosarcoma
Advancing Transplantation Outcomes in Children
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Primary outcomeIncidence of de novo Donor Specific Antibody (dnDSA) (central lab) OR decline in estimated glomerular filtration rate (eGFR) >7.5 mL/min/1.73m^2 (central lab)
Kidney Transplant
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
SponsorUniversity of Miami
Primary outcomeEvent-Specific Survival Comparisons
Type 1 Diabetes
Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive Therapy
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Primary outcomeTo determine if the rate of relapse at 24 months after CSA discontinuation can be improved by conversion to sirolimus in severe aplastic anemia patients who have responded to IST.
Severe Aplastic Anemia
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Primary outcomePercentage of Participants With Clinical Benefit
Advanced Renal Cell Carcinoma
HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide
SponsorCenter for International Blood and Marrow Transplant Research
Primary outcomeOverall Survival
Myelodysplastic Syndrome (MDS)Chronic Lymphocytic Leukemia (CLL)Chemotherapy-sensitive LymphomaAcute Lymphoblastic Leukemia (ALL)/T Lymphoblastic LymphomaAcute Myelogenous Leukemia (AML)Acute Biphenotypic Leukemia (ABL)Acute Undifferentiated Leukemia (AUL)
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Primary outcomeThe primary outcome is to explore the safety of sirolimus in the management of BSCMs.
Cavernous MalformationsIntracerebral HemorrhageBrainstem Stroke
Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation
SponsorCity of Hope Medical Center
Primary outcomeGraft-versus-host Disease Free Relapse Free (GRFS) at 1 Year
Acute LeukemiaHematologic and Lymphocytic DisorderMyelodysplastic SyndromePrimary MyelofibrosisSecondary Myelofibrosis
Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy
SponsorNational Eye Institute (NEI)
Primary outcomeRate of change in area of geographic atrophy
Geographic Atrophy
Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations
SponsorCentre Hospitalier Universitaire, Amiens
Primary outcomeTreatment efficacy at M12
Arteriovenous Malformations
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
SponsorHannover Medical School
Primary outcomeProgression free rate
Head and Neck Squamous Cell Carcinoma
Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
SponsorBeth Israel Deaconess Medical Center
Primary outcome4-month Progression-Free Survival Rate
Renal Cell CarcinomaKidney Cancer
Rapamycin - Effects on Alzheimer's and Cognitive Health
SponsorThe University of Texas Health Science Center at San Antonio
Primary outcomeNumber of adverse events
Mild Cognitive ImpairmentAlzheimer Disease
Discovery of Sirolimus Sensitive Biomarkers in Blood
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Primary outcomeNumber of Sirolimus-Sensitive Plasma Protein Biomarkers in Lymphangioleiomyomatosis (LAM) Participants
Lymphangioleiomyomatosis
CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
SponsorNational Cancer Institute (NCI)
Primary outcomePercentage of patients being progression free
Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Tumor
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
SponsorUniversity of Cincinnati
Primary outcomePercentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
COVID-19
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
SponsorNational Cancer Institute (NCI)
Primary outcomeProportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
Recurrent Mantle Cell Lymphoma
Temsirolimus as Second-line Therapy in HCC
SponsorUniversity of Tennessee Cancer Institute
Primary outcomeDisease Progression
Unresectable or Metastatic Hepatocellular Carcinoma
Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis
SponsorUniversity Hospital, Toulouse
Primary outcomeEvaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis.
Familial Adenomatous Polyposis
Enhancing Self Regulation Among Smokers
SponsorMedical University of South Carolina
Primary outcomeCraving Levels in Response to Cue
Smoking CessationSmoking, CigaretteNicotine Dependence
Sirolimus for Leigh Syndrome
Primary outcomeRate of Adverse Events
Leigh Syndrome
Prospective Pilot Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-grade Pineoblastoma
SponsorUniversity of Regensburg
Primary outcomeThe primary endpoint is progression-free survival (PFS)
Pineoblastoma
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
SponsorStanford University
Primary outcomeAcute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)
Hematologic DiseasesAcute-graft-versus-host DiseaseLeukemiaNon-Hodgkin Lymphoma (NHL)Hodgkin Lymphoma
High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant
SponsorBarbara Ann Karmanos Cancer Institute
Primary outcomeIncidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin
Refractory Multiple MyelomaStage I Multiple MyelomaStage II Multiple MyelomaStage III Multiple Myeloma
CCI-779 in Treating Patients With Malignant Glioma
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Brain and Central Nervous System Tumors
Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
SponsorNational Cancer Institute (NCI)
Primary outcomeRecommended Dose Level for Phase II Testing (RPTD) (Phase I)
Male Breast CarcinomaRecurrent Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7
Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
SponsorPeking University People's Hospital
Primary outcomeProportion of Treg cells in peripheral blood
Sjögren's Syndrome
SARC023: Ganetespib and Sirolimus in Patients With MPNST (Malignant Peripheral Nerve Sheath Tumors)
SponsorSarcoma Alliance for Research through Collaboration
Primary outcomeNumber of Dose Limiting Toxicities of Ganetespib When Administered in Combination With Sirolimus.
Malignant Peripheral Nerve Sheath Tumors (MPNST)Sarcoma
CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)
SponsorCentral European Society for Anticancer Drug Research
Primary outcomerecommended dose
Prostatic Neoplasms
Evaluating Rapamycin Treatment in Alzheimer's Disease Using Positron Emission Tomography
SponsorKarolinska Institutet
Primary outcomeChange in cerebral glucose metabolism
Alzheimer Disease
Safety of Simvastatin in LAM and TSC
SponsorUniversity of Pennsylvania
Primary outcomeSafety of Simvastatin in the Treatment of LAM-S and LAM-TS Patients
LymphangioleiomyomatosisTuberous Sclerosis Complex
Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
SponsorM.D. Anderson Cancer Center
Primary outcomeMaximum Tolerated Dose (MTD) of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
Advanced Cancers
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
SponsorM.D. Anderson Cancer Center
Primary outcomeMaximum tolerated dose (MTD) of bevacizumab, defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT)
Advanced Malignant NeoplasmCastleman DiseaseDigestive System CarcinomaErdheim-Chester DiseaseLip and Oral Cavity CarcinomaLymphangioleiomyomatosisMalignant Endocrine NeoplasmMalignant Female Reproductive System NeoplasmMalignant Male Reproductive System NeoplasmMalignant NeoplasmMalignant Respiratory Tract NeoplasmMalignant Thoracic NeoplasmMalignant Urinary System NeoplasmMesothelial NeoplasmMetastatic Malignant NeoplasmMetastatic Urothelial CarcinomaNeurofibromatosis Type 2Recurrent Adult Soft Tissue SarcomaRecurrent Breast CarcinomaRecurrent Childhood Soft Tissue SarcomaRecurrent Digestive System CarcinomaRecurrent Female Reproductive System CarcinomaRecurrent Male Reproductive System CarcinomaRecurrent Malignant NeoplasmRecurrent Pharyngeal CarcinomaRecurrent Thyroid Gland CarcinomaRefractory Malignant NeoplasmSoft Tissue NeoplasmStage III Breast Cancer AJCC v7Stage III Pharyngeal CancerStage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7Stage IV Pharyngeal CancerStage IVA Pharyngeal CancerStage IVB Pharyngeal CancerStage IVC Pharyngeal CancerThyroid Gland Neoplasm
Rapamycin With Grapefruit Juice for Advanced Malignancies
SponsorUniversity of Chicago
Primary outcomePharmacokinetic interaction
TumorsNeoplasm Metastasis
Rapamycin Plus Bevacizumab in Advanced Cancers
SponsorUniversity of Chicago
Advanced CancerMetastatic Cancer
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
Primary outcomenumber of participants with adverse events based on the CTCAE v.4
B-cell Lymphoma Refractory
131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
SponsorColumbia University
Primary outcomeGraft failure rate
Sickling Disorder Due to Hemoglobin S
Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
SponsorNational Cancer Institute (NCI)
Primary outcomeMTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0
Recurrent MelanomaRecurrent Renal Cell CancerStage IV MelanomaStage IV Renal Cell CancerUnspecified Adult Solid Tumor, Protocol Specific
A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary outcomesafety and feasibility
Metastatic Pancreatic Adenocarcinoma
Temsirolimus and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
SponsorNational Cancer Institute (NCI)
Primary outcomeMaximum tolerated dose of temsirolimus
Refractory Multiple MyelomaStage I Multiple MyelomaStage II Multiple MyelomaStage III Multiple Myeloma
Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis
SponsorBrigham and Women's Hospital
Primary outcomeSafety of Combination Therapy With Sirolimus and Hydroxychloroquine in LAM Patients
Lymphangioleiomyomatosis
NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Bioavailability Study
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
SponsorMassachusetts General Hospital
Primary outcomeTo determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Pancreatic Adenocarcinoma
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies
SponsorM.D. Anderson Cancer Center
Primary outcomeNumber of Participants achieving engraftment without severe Graft-versus-host disease (GVHD)
LeukemiaLymphomaMyeloma