Abstract

This single institution Phase I study of temozolomide will define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and the pharmacokinetics of temozolomide when administered on a twice a day schedule (q 12hr) for 5 days. The primary objective is to characterize the safety profile and determine the DLT and MTD of temozolomide when given orally, to adult patients with advanced cancer. The secondary objectives are a) To characterize the pharmacokinetics of temozolomide when given twice a day (q12 hour) over 5 days, after a bolus dose of 200 mg/m2 to adult patients with advanced cancer b) To evaluate the biochemical modulary effect of temozolomide on the depletion of alkyltransferase (ATase) by measuring ATase levels in circulating peripheral blood lymphocytes and, at the MTD, in tumor biopsies c) To evaluate the antitumor activity of temozolomide when given twice a day (q 12 hour) over 5 days after a bolus dose of 200 mg/m2 to adult patients with advanced cancer. To date seven subjects have been enrolled.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-34
Application #
5219153
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
34
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Juraschek, Stephen P; Appel, Lawrence J; Miller 3rd, Edgar R (2017) Metoprolol Increases Uric Acid and Risk of Gout in African Americans With Chronic Kidney Disease Attributed to Hypertension. Am J Hypertens 30:871-875
O'Toole, John F; Bruggeman, Leslie A; Madhavan, Sethu et al. (2017) The Cell Biology of APOL1. Semin Nephrol 37:538-545
Chen, Teresa K; Tin, Adrienne; Peralta, Carmen A et al. (2017) APOL1 Risk Variants, Incident Proteinuria, and Subsequent eGFR Decline in Blacks with Hypertension-Attributed CKD. Clin J Am Soc Nephrol 12:1771-1777
Catalano, Patrick M; Shankar, Kartik (2017) Obesity and pregnancy: mechanisms of short term and long term adverse consequences for mother and child. BMJ 356:j1

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