Abstract

This study will be a 3-way crossover dosing with two additional periods to determine the bioavailability of oral TMTX in patients with cancer. Trimetrexate glucoronate (TMTX) has been tested intravenously in cancer patients and has shown some activity against various tumor types. Limited studies have been conducted with oral TMTX in AIDS patients with pneumocystis carinii pneumonia and/or toxoplasmosis. Oral dosing in cancer patients will be determined based on information obtained from pharmocokinetics data collected during the study. TMTX administered with leucovorin suggests diminished toxicity. TMTX could potentially be an orally administered chemotherapy used to treat tumors which show transport-resistance to classical antifols such as methotrexate while displaying acceptable toxicity.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000633-24
Application #
5220946
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
24
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Gregg, L Parker; Tio, Maria Clarissa; Li, Xilong et al. (2018) Association of Monocyte Chemoattractant Protein-1 with Death and Atherosclerotic Events in Chronic Kidney Disease. Am J Nephrol 47:395-405
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Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Sakhaee, Khashayar; Poindexter, John; Aguirre, Crystal (2016) The effects of bariatric surgery on bone and nephrolithiasis. Bone 84:1-8
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Foglia, Elizabeth E; Nolen, Tracy L; DeMauro, Sara B et al. (2015) Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled. JAMA 313:2377-9

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