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Temodar Medical Research Studies

Up-to-date List of Temodar 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 Temodar Medical Research Studies

Rank Status Study
1 Recruiting Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas
Condition: Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas
Interventions: Drug: CTO;   Drug: CTO and Temodar®;   Drug: CTO, Temodar®, Radiation therapy
Outcome Measures: To determine the MTD/RD of single agent CTO in patients with advanced or metastatic solid tumors; or CTO in combination with Temodar® in patients with glioblastoma or other recurrent malignant gliomas;   Preliminary tumor response;   Pharmacokinetics (maximum concentration, Tmax, AUC, T1/2, clearance, volume of distribution);   Voluntary Exploratory objective;   Exploratory Objective
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 Unknown  Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
Condition: Glioblastoma
Interventions: Drug: Temozolomide;   Drug: Temozolomide plus Thalidomide
Outcome Measures: Proportion of patients with progression free survival;   Proportion of patients with a clinical response. Time to disease progression. Progression free survival.
4 Recruiting WEE1 Inhibitor MK-1775, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma Multiforme
Conditions: Adult Giant Cell Glioblastoma;   Adult Glioblastoma;   Adult Gliosarcoma;   Recurrent Adult Brain Tumor
Interventions: Drug: WEE1 inhibitor MK-1775;   Radiation: radiation therapy;   Drug: temozolomide;   Other: pharmacological study;   Other: laboratory biomarker analysis
Outcome Measures: MTD of WEE1 inhibitor MK-1775 with 6 weeks of RT and temozolomide, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Arm I);   MTD of WEE1 inhibitor MK-1775 with adjuvant temozolomide, graded according to the NCI CTCAE v4.0 (Arm II);   Incidence of toxicities, graded according to the NCI CTCAE v4.0;   Overall survival;   Progression-free survival
5 Recruiting A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Condition: Glioblastoma
Interventions: Drug: BKM120 + temozolomide;   Drug: BKM120 +temozolomide with/without radiotherapy
Outcome Measures: Dose Limiting Toxicity (DLT);   No of participants with Adverse events based on abnormal laboratory results, abnormal electrocardiogram (ECG) findings;   Objective response rate (ORR);   Progression free survival (PFS);   Overall survival (OS);   Plasma concentration-time profiles and basic pharmacokinetic parameters of BKM120 and temozolomide (Cmax, tmas, AUC, half-life)
6 Recruiting Trial Of Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed Glioblastoma Multiforme And Anaplastic Astrocytoma
Conditions: Glioblastoma Multiforme;   Anaplastic Astrocytoma
Intervention: Drug: Super-Selective Intraarterial Intracranial Infusion of Temozolomide
Outcome Measures: Determine the safety of superselective intra-arterial cerebral infusion of Temozolomide up to a dose of 250 mg/m2 IA.;   Composite overall response rate.;   Six-month progression-free survival (PFS) and overall survival (OS)
7 Recruiting Phase I Study of Olaprib and Temozolomide for Ewings Sarcoma
Condition: Ewing Sarcoma
Interventions: Drug: Olaparib;   Drug: Temozolomide
Outcome Measures: Determine MTD of olaparib and temozolomide;   Evaluate safety and tolerability of olaparib/temozolomide combination;   Objective response in tumor dimensions to olaparib/temozolomide;   Explore variations in PARP activity and tumor characteristics
8 Recruiting BMN-673 and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies
Conditions: Recurrent Adult Acute Lymphoblastic Leukemia;   Recurrent Childhood Acute Lymphoblastic Leukemia;   Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;   Unspecified Adult Solid Tumor, Protocol Specific;   Unspecified Childhood Solid Tumor, Protocol Specific
Interventions: Drug: PARP inhibitor BMN-673;   Drug: temozolomide;   Other: laboratory biomarker analysis;   Other: pharmacological study
Outcome Measures: MTD of PARP inhibitor BMN-673 and temozolomide, defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicities (DLT) (Phase I Part A1);   Objective response in patients with Ewing sarcoma or Peripheral PNET assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and criteria for CNS tumors (Phase I Part A2);   Pharmacokinetic (PK) parameters of PARP inhibitor BMN-673 (Phase I Part A);   Best response of disease to PARP inhibitor BMN-673 plus temozolomide in Ewing sarcoma or peripheral PNET patients determined according to RECIST v1.1 (Phase II Parts B and C);   Best response of disease to PARP inhibitor BMN-673 plus temozolomide in patients with ALL using the leukemia rating scale and peripheral blood counts (Phase II Parts B and C);   Incidence of toxicities, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (Phase II Parts B and C)
9 Unknown  Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients
Condition: Glioblastoma
Intervention: Drug: Temozolomide
Outcome Measures: to determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months;   safety and adverse event profile of prolonged adjuvant Temozolomide
10 Recruiting Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
Conditions: Gastrinoma;   Glucagonoma;   Insulinoma;   Islet Cell Carcinoma;   Pancreatic Polypeptide Tumor;   Recurrent Islet Cell Carcinoma;   Somatostatinoma
Interventions: Drug: temozolomide;   Drug: capecitabine;   Other: laboratory biomarker analysis
Outcome Measures: PFS;   RR defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1;   Overall survival;   Toxicity rates using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
11 Recruiting Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
Conditions: Recurrent Childhood Medulloblastoma;   Recurrent Childhood Pineoblastoma;   Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
Interventions: Drug: temozolomide;   Drug: irinotecan hydrochloride;   Biological: bevacizumab
Outcome Measures: Overall survival for each treatment arm;   Response rate for each treatment arm;   Event-free survival
12 Recruiting Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
Conditions: Glioblastoma Multiforme;   Glioma;   Gliosarcoma;   Malignant Brain Tumor
Interventions: Drug: Indoximod;   Drug: Temozolomide
Outcome Measures: Phase 2 Dosing;   Number of Participants with Adverse Events as a Measure of Safety and Tolerability;   Overall Dose of Temozolomide Delivered Versus Historical Control;   Pharmacokinetics
13 Recruiting Bevacizumab, Irinotecan and Temozolomide for Relapsed or Refractory Neuroblastoma
Condition: Neuroblastoma
Intervention: Drug: Bevacizumab, Irinotecan and Temozolomide
Outcome Measures: To evaluate tumor responses to combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.;   To determine the toxicity of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.;   To evaluate changes in angiogenic markers after treatment with the combination of irinotecan, temozolomide and bevacizumab.;   To measure time to progression in patients with resistant NB treated with the combination of irinotecan, temozolomide and bevacizumab.
14 Recruiting Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors
Conditions: Central Nervous System (CNS) Metastases;   Brain Metastases
Interventions: Drug: Topotecan;   Drug: Temozolomide
Outcome Measures: Radiologic Response;   Median Overall Survival
15 Recruiting Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM
Condition: Glioblastoma
Interventions: Procedure: Gross total resection and Gliadel(R) wafers implanted;   Radiation: GammaKnife(R) stereotactic Radiosurgery;   Radiation: Standard fractionated radiation therapy;   Drug: Temozolomide
Outcome Measures: Change in health related quality of life;   time without Cognitive impairment;   incidence of symptomatic radiation necrosis;   Disease-free survival;   Overall survival
16 Recruiting Doxycycline, Temozolomide and Ipilimumab in Melanoma
Condition: Melanoma
Interventions: Drug: Doxycycline;   Drug: Ipilimumab;   Drug: Temozolomide
Outcome Measure: Overall Response Rate
17 Recruiting Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas
Conditions: Childhood Mixed Glioma;   Untreated Childhood Anaplastic Astrocytoma;   Untreated Childhood Brain Stem Glioma;   Untreated Childhood Fibrillary Astrocytoma;   Untreated Childhood Giant Cell Glioblastoma;   Untreated Childhood Glioblastoma;   Untreated Childhood Gliosarcoma
Interventions: Drug: veliparib;   Drug: temozolomide;   Radiation: 3-dimensional conformal radiation therapy;   Radiation: intensity-modulated radiation therapy;   Other: pharmacological study;   Other: laboratory biomarker analysis
Outcome Measures: Maximum-tolerated dose of veliparib defined as highest dose level with fewer than 2 dose limiting toxicities in 6 patients as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I);   Feasibility of intra-patient dose escalation of temozolomide during maintenance therapy with veliparib (Phase I and II);   Overall survival (Phase II);   PFS (Phase II);   Number of pseudo progression;   Pharmacokinetic parameters of veliparib
18 Not yet recruiting Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Conditions: Adult Giant Cell Glioblastoma;   Adult Glioblastoma;   Adult Gliosarcoma
Interventions: Drug: temozolomide;   Drug: veliparib;   Other: placebo;   Other: laboratory biomarker analysis
Outcome Measures: Overall survival (OS);   Progression-free survival (PFS);   Objective tumor response, defined as complete response or partial response as specified in the Revised Assessment in Neuro-Oncology criteria;   Overall adverse event rates for grade 3 or higher adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
19 Recruiting Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
Conditions: Brain Cancer;   Glioblastoma Multiforme
Interventions: Drug: Vorinostat;   Drug: Erlotinib;   Drug: Temozolomide
Outcome Measures: Maximum Tolerated Dose (MTD);   Progression Free Survival (PFS)
20 Recruiting Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Condition: Recurrent Small Cell Lung Cancer
Interventions: Drug: veliparib;   Drug: temozolomide;   Other: placebo;   Other: laboratory biomarker analysis
Outcome Measures: Progression-free survival, calculated as the proportion of patients alive and without evidence of disease;   ORR by RECIST 1.1 criteria;   Overall survival;   Incidence of adverse events

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

A major focus of Temodar 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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