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Ismo Medical Research Studies

Up-to-date List of Ismo Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Ismo Medical Research Studies

Rank Status Study
1 Recruiting Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma
Conditions: Locally Advanced Basal Cell Carcinoma;   Skin Cancer;   Cutaneous Malignancy
Interventions: Drug: Vismodegib;   Radiation: Radiation therapy
Outcome Measures: Local-regional control from therapy completion;   Probability of progression-free survival;   Initial toxicity during the 3 months immediately after completion of protocol therapy.;   Feasibility of administering concurrent Vismodegib with radiation therapy determined by the proportion of patients discontinuing treatment due to toxicity during the study;   Response rate (as per RECIST) of the primary site and regionally involved areas following all treatment components at 3 months after the completion of protocol therapy.;   Clinical response to Vismodegib and radiation therapy determined by the proportion of patients with a decrease of basal cell carcinoma within the irradiated planning tumor volumes in patients who completed therapy;   Adverse events reported during the drug-alone and combined-modality components of the protocol regimen during treatment;   Proportion of any adverse events (CTCAE, v. 4.1) assessed to be related during the drug-alone and combined-modality components of the protocol regimen during treatment;   Proportion of patients experiencing Grade 4-5 adverse events related to the induction or concurrent treatment components of the protocol regimen (that is not definitely related to disease progression)
2 Recruiting Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway
Conditions: Histologically Confirmed Medulloblastoma;   Activation of the Sonic Hedgehog (SHH) Pathway
Interventions: Drug: Vismodegib;   Drug: Temozolomide
Outcome Measures: To evaluate the safety of a fixed dose of Vismodegib in combination with (phase I)temozolomide in adult patients with recurrent, progressive, or refractory to standard therapy medulloblastoma;   To estimate the efficacy of Vismodegib in combination with temozolomide in adult patients with recurrent, progressive, or refractory to standard therapy medulloblastoma (phase II);   To collect preliminary results on the 6-month progression-free rate of the combination Vismodegib + temozolomide (phase I);   To estimate in the two study arms the objective response rate after 6 months of treatment (phase II);   To estimate in the two study arms the duration of treatment response (phase II);   To estimate in the two study arms the best overall response obtained during the study (phase II);   To estimate in the two study arms the progression-free survival (PFS)(phase II);   To estimate in the two study arms the time to treatment failure (phase II);   frequency of adverse events based on the common toxicity criteria (CTC-AE-V4.0) grade
3 Not yet recruiting A Study of Vismodegib in Men With Metastatic CRPC With Accessible Metastatic Lesions for Tumor Biopsy
Condition: Prostate Cancer
Intervention: Drug: Vismodegib
Outcome Measures: The proportion of mCRPC patients treated with Vismodegib who achieve a pharmacodynamic (PD) response in tumor biopsies;   Suppression by Vismodegib in tumor tissue of Hh-regulated transcripts;   Suppression by Vismodegib in markers of the Hh pathway in skin punch-biopsies;   Suppression by Vismodegib in CTCs of the Hh pathway and AR pathway;   The effect of Vismodegib on PSA responses;   The safety/tolerability and drug-related toxicities of Vismodegib
4 Recruiting Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma
Condition: Pontine Glioma
Intervention: Drug: Vismodegib
Outcome Measures: Determine the Progression Free Survival (PFS) of Participants using days until progression;   Number of Participants with Adverse Events as a Measure of Safety and Tolerability;   Determine the Median overall survival (OS) of Participants;   Evaluate the impact of Quality of Life of children receiving Vismodegib using PedsQL questionnaires;   Determine the response rates of Participants based on activation (or no activation) of their hedgehog signaling pathway
5 Unknown  Vismodegib for Treatment of Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
Interventions: Drug: Vismodegib;   Drug: Placebo
Outcome Measures: Mohs Micrographic Surgery (MMS);   Complete Response Rate
6 Recruiting Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia
Conditions: Diffuse Large B-cell Lymphoma;   "Indolent" Non-hodgkin Lymphoma;   Primary Central Nervous System Lymphoma;   Chronic Lymphocytic Leukemia
Intervention: Drug: Vismodegib
Outcome Measures: The best overall response rate(ORR);   Overall Response rate;   Progression Free Survival (PFS);   Response Duration;   Overall survival;   Correlation between Hedgehog (Hh) signaling in the tumor and the efficacy of Vismodegib;   Safety endpoints
7 Recruiting Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma
Conditions: Adult Alveolar Soft-part Sarcoma;   Adult Angiosarcoma;   Adult Desmoplastic Small Round Cell Tumor;   Adult Epithelioid Hemangioendothelioma;   Adult Epithelioid Sarcoma;   Adult Extraskeletal Chondrosarcoma;   Adult Extraskeletal Osteosarcoma;   Adult Fibrosarcoma;   Adult Leiomyosarcoma;   Adult Liposarcoma;   Adult Malignant Fibrous Histiocytoma;   Adult Malignant Mesenchymoma;   Adult Neurofibrosarcoma;   Adult Rhabdomyosarcoma;   Adult Synovial Sarcoma;   Chondrosarcoma;   Clear Cell Sarcoma of the Kidney;   Conjunctival Kaposi Sarcoma;   Dermatofibrosarcoma Protuberans;   Gastrointestinal Stromal Tumor;   Metastatic Adult Malignant Fibrous Histiocytoma of Bone;   Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;   Metastatic Osteosarcoma;   Ovarian Sarcoma;   Recurrent Adult Malignant Fibrous Histiocytoma of Bone;   Recurrent Adult Soft Tissue Sarcoma;   Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;   Recurrent Kaposi Sarcoma;   Recurrent Osteosarcoma;   Recurrent Uterine Sarcoma;   Small Intestine Leiomyosarcoma;   Stage III Adult Soft Tissue Sarcoma;   Stage III Uterine Sarcoma;   Stage IV Adult Soft Tissue Sarcoma;   Stage IV Uterine Sarcoma
Interventions: Drug: Vismodegib;   Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097;   Other: laboratory biomarker analysis;   Other: pharmacological study
Outcome Measures: Maximum-tolerated dose of gamma-secretase inhibitor RO4929097, defined as the dose level where no more than 1 out of 6 patients experience DLT at the highest dose level below the MAD, graded according to NCI-CTCAE version 4.0 (Phase Ib);   Progression-free survival as defined by RECIST 1.1 (Phase II);   Change in protein levels from pre- and post-treatment biopsies (Phase Ib and II);   Response rate (CR + PR) as assessed by RECIST 1.1 (Phase Ib and II);   Overall survival (Phase II)
8 Recruiting Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
Conditions: Acinar Cell Adenocarcinoma of the Pancreas;   Duct Cell Adenocarcinoma of the Pancreas;   Recurrent Pancreatic Cancer;   Stage IV Pancreatic Cancer;   Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: Vismodegib;   Drug: sirolimus;   Procedure: positron emission tomography;   Procedure: computed tomography;   Other: pharmacological study;   Other: laboratory biomarker analysis;   Radiation: fludeoxyglucose F 18
Outcome Measures: MTD (Cohort I) ) and toxicity profile of combination of Vismodegib plus sirolimus every 28 days.;   Adverse events (AEs) profile in terms of the number and severity of all adverse events (overall, by dose-level, and by tumor group) at baseline, at each dose level and at 30 days after completion of study treatment;   Time to treatment failure;   Antitumor effect of molecularly targeted agents non-invasively by F18-FDG PET or PET/CT (Cohort II)
9 Not yet recruiting Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma Resectable
Interventions: Drug: gemcitabine;   Drug: Vismodegib;   Procedure: Neoadjuvant chemotherapy
Outcome Measures: "Dynamic" tumor response rate as defined by a 20% modification of tumoral perfusion and cellular density parameters.;   Number of participants with adverse events as assessed by National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0.
10 Recruiting A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myleodysplastic Syndrome
Condition: Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
Interventions: Drug: Vismodegib;   Drug: cytarabine
Outcome Measures: Overall response rate (CR, CRi or PR) at Week 8;   Overall response rate at any time during study treatment;   Duration of response;   Overall survival;   Safety: Incidence of adverse events, according to NCI CTCAE v4.0;   Pharmacokinetics: Steady-state plasma concentration;   Cohort 2: Pharmacokinetics od cytarabine in combination with Vismodegib: Area under the concentration-time curve (AUC)
11 Recruiting Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes
Condition: Basal Cell Carcinoma
Intervention: Drug: Vismodegib (150 mg PO daily)
Outcome Measures: Efficacy;   Safety;   Onset of efficacy;   Patient reported outcomes
12 Recruiting A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
Interventions: Drug: Vismodegib;   Drug: Placebo
Outcome Measures: Percent change in surgical defect area;   Complete response rate;   Partial response rate;   Actual change in expected surgical defect area;   Occurrence of unconnected residual tumor;   Percent change in actual tumor-free margin excision area;   Cumulative recurrence rate of the target basal cell carcinoma at Weeks 12, 24, and 52 post-surgery;   Safety: Incidence of adverse events
13 Recruiting STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
Intervention: Drug: Vismodegib
Outcome Measures: Safety: Incidence of adverse events;   Quality of life: Skindex-16 questionnaire;   Symptoms in metastatic BCC patients: M.D. Anderson Symptom Inventory (MDASI);   Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST);   Time to response;   Duration of response;   Progression-free survival;   Overall survival
14 Recruiting A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf, and Erivedge Treatment Targeted Against Certain Mutations in Cancer Patients
Condition: Neoplasms
Interventions: Drug: Trastuzumab [Herceptin];   Drug: Pertuzumab [Perjeta];   Drug: Erlotinib [Tarceva];   Drug: Vemurafenib [Zelboraf];   Drug: Vismodegib [Erivedge]
Outcome Measures: Overall response rate as determined by the investigator according to response evaluation in solid tumors (RECIST) v. 1.1 criteria;   Disease control rate, defined as the proportion of patients whose best response is complete response, partial response or stable disease;   Progression-free survival, defined as the time from first study treatment to until disease progression as assessed by the investigator, or death from any cause;   Overall survival, defined as the survival rate 1 year from the date of first treatment
15 Recruiting A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
Condition: Medulloblastoma
Interventions: Radiation: Craniospinal Irradiation with boost to the primary tumor site;   Drug: Cyclophosphamide;   Drug: Cisplatin;   Drug: Vincristine;   Drug: Vismodegib;   Drug: Pemetrexed;   Drug: Gemcitabine;   Other: Aerobic Training;   Other: Neurocognitive Remediation
Outcome Measures: Progression-free survival distribution (Stratum W1);   Progression free survival distribution (Stratum N1);   Change in VO2 peak values;   Change in spatial span backward standard score;   Compare progression-free survival by strata with prior St. Jude SJMB03 study participants;   Compare overall survival by strata with prior St. Jude SJMB03 study participants;   Proportion of patients able to complete protocol therapy;   Number of patients who go off treatment for reasons other than progressive disease;   Number of local failures;   Change in hand grip strength;   Change in range of motion;   Change in overall flexibility;   Change in motor proficiency;   Change in quality of life (QOL) score;   Change in fatigue score;   Change in measure of memory function;   Change in measure of attention;   Change in executive function score;   Change in sleep;   Association between baseline cognitive performance and sleep quality;   Association between baseline cognitive performance and sleep quantity;   Association between baseline cognitive performance and fatigue;   Longitudinal change in measure of intellectual function;   Association of demographic and clinical factors with change in intellectual function;   Longitudinal change in measure of academic ability;   Association of demographic and clinical factors with change in academic ability;   Longitudinal change in measure of attention;   Association of demographic and clinical factors with change in attention;   Longitudinal change in measure of memory;   Association of demographic and clinical factors with change in memory;   Longitudinal change in measure of cognitive processing speed function;   Association of demographic and clinical factors with change in cognitive processing speed;   Longitudinal change in measure of neurocognitive executive function;   Association of demographic and clinical factors with change in neurocognitive executive function;   Change in measure of processing speed;   Change in measure of executive function ability;   Change in measure of attention among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone);   Change in measure of processing speed among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone);   Change in measure of executive function among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone);   Change in measure of attention between participants who received computer-based intervention VS. those who did not;   Change in measure of working memory between participants who received computer-based intervention VS. those who did not;   Change in measure of processing speed between participants who received computer-based intervention VS. those who did not;   Change in measure of executive function between participants who received computer-based intervention VS. those who did not
16 Recruiting Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas
Condition: Metastatic Pancreatic Cancer
Intervention: Drug: Gemcitabine, nab-Paclitaxel, GDC-0449
Outcome Measures: To evaluate the progression free survival with the combination of GDC-0449 with Gemcitabine and nab-paclitaxel.;   To evaluate the safety of this combination in patients with metastatic adenocarcinoma of the pancreas.;   To evaluate other efficacy measures and the changes in the pancreatic cancer stem cells with the combination of GDC-0449 with gemcitabine and nab-Paclitaxel.
17 Recruiting Levocarnitine in Treating Patients With Vismodegib-Associated Muscle Spasms
Condition: Musculoskeletal Complications
Interventions: Dietary Supplement: levocarnitine;   Other: placebo;   Other: questionnaire administration
Outcome Measures: Mean difference in muscle spasm number in a week;   Mean severity of muscle spasm;   Proportion of participants who answered "yes" to functional and psychosocial effects of muscle spasms
18 Not yet recruiting Ribavirin and Hedgehog Inhibitor With or Without Azacytidine in AML
Condition: Acute Myeloid Leukemia
Interventions: Drug: Ribavirin;   Drug: Hedgehog inhibitor;   Drug: Azacytidine
Outcome Measures: Efficacy will be measured by overall response rate (ORR).;   Time to response;   Duration of response;   One year survival;   Overall survival;   Hematologic improvement defined by the number of individual, positively affected cell lines (erythroid, neutrophil and platelet cells) per patient.;   Number of participants with Adverse Events as a Measure of Safety and Tolerability;   Changes in eIF4E expression, localization, and signalling pathways (measured by immuno-histochemical analysis, PCR or western blot) and correlating with each patient's overall response.

These studies may lead to new treatments and are adding insight into Ismo etiology and treatment.

A major focus of Ismo research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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