Track topics on Twitter Track topics that are important to you
To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide
Objectives of study are to determine activity of combo of Irinotecan + Temozolomide & to further characterize any toxicity associated w combo of Irinotecan + Temozolomide. Temozolomide administered orally at 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide administered on day 1 of treatment cycle & every 24hrs thereafter for 5 days w treatment cycles repeated every 6wks. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. At end of 3rd cycle/if cycles are stopped early for toxicity or progression, subject will undergo radiation therapy. CPT-11 administered intravenously in fasting state over 90min. CPT-11 will begin 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11 administered on days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving CYP3A4-inducing antiepileptic drugs due to increased drug clearance produced by these agents. For pts receiving EIAEDs including phenytoin, fosphenytoin, oxcarbazepine, phenobarbital/ primidone, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of125 mg/m2 administered.
Subjects have newly diagnosed histologically proven supratentorial glioblastoma multiforme. Toxicities associated w CPT-11 are anemia, decreased blood counts, diarrhea, constipation, nausea, vomiting, tiredness, fever, mouth sores, dehydration, rash, itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating, hot flashes, hair loss, inflammation of liver, flu-like symptoms, decreased urine output, shortness of breath,& pneumonia. Low white blood cell & platelet counts may be associated w risk of infection/bleeding, respectively. Irinotecan has also caused birth defects in animals. Most frequent toxicities in earlier studies have been low white blood cells & diarrhea, & death has been seen from these & other side effects. Temozolomide has been well tolerated by both adults & children w most common toxicity being mild myelosuppression. Other, less likely, potential toxicities include nausea & vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy, hepatotoxicity, anorexia, fatigue & hyperglycemia. Hypersensitivity reactions have not yet been noted w Temozolomide. As in case w many anti-cancer drugs, Temozolomide may be carcinogenic.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Temodar and Irinotecan
Duke University Health System
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:32:57-0400
Objectives: To determine maximum tolerated dose of CPT-11 when administered following Temodar plus O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar pl...
This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately following a sta...
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following sur...
Primary Objectives: - To determine the maximum tolerated dose Sarasar (SCH66336, lonafarnib) when combined with Temodar (temozolomide) in an alternating week schedule. - ...
Objectives: 1. To determine the safety, tolerability and efficacy of dietary methionine restriction for 7 days alternating with Temodar® (Temozolomide) given once a day for seven ...
Evaluate the toxicity and efficacy of adjuvant temozolomide (TMZ) and irinotecan (CPT-11) for 12 months following concurrent chemo-radiation in newly diagnosed glioblastoma (GBM).
Although irinotecan is an important anticancer drug for treating colorectal cancer, its dose-dependent side effects limited its clinical application. Thus, it's important to develop low-toxic candidat...
Because of the great interest for research on the potential use of cannabis preparations as co-medication for alleviation of toxic effects in cancer management, we investigated the influence of Δ-tet...
Cholinergic syndrome is an acute adverse event frequently observed in patients administered irinotecan, and can sometimes negatively affect their quality of life. In some manifestations of the syndrom...
Irinotecan is an anticancer drug with a broad spectrum of activity, characterized by multistep and complex pharmacology. Regardless of its schedule of administration, neutropenia and delayed-type diar...
Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)
A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures.
A TGF-beta subtype that was originally identified as a GLIOBLASTOMA-derived factor which inhibits the antigen-dependent growth of both helper and CYTOTOXIC T LYMPHOCYTES. It is synthesized as a precursor molecule that is cleaved to form mature TGF-beta2 and TGF-beta2 latency-associated peptide. The association of the cleavage products results in the formation a latent protein which must be activated to bind its receptor.
Intracranial tumors originating in the region of the brain inferior to the tentorium cerebelli, which contains the cerebellum, fourth ventricle, cerebellopontine angle, brain stem, and related structures. Primary tumors of this region are more frequent in children, and may present with ATAXIA; CRANIAL NERVE DISEASES; vomiting; HEADACHE; HYDROCEPHALUS; or other signs of neurologic dysfunction. Relatively frequent histologic subtypes include TERATOMA; MEDULLOBLASTOMA; GLIOBLASTOMA; ASTROCYTOMA; EPENDYMOMA; CRANIOPHARYNGIOMA; and choroid plexus papilloma (PAPILLOMA, CHOROID PLEXUS).
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...