Katherine E. Warren, M.D.

Katherine E. Warren, M.D.
Special Volunteer

Dr. Warren departed the NCI in the spring of 2019. She headed the Pediatric Neuro-Oncology Section and led preclinical and clinical efforts in developing new therapeutic strategies for the treatment of children with tumors of the central nervous system. She has extensive experience in drug development for children with CNS tumors, including preclinical pharmacokinetic studies, and early phase clinical trials in children. Her research entailed a multifaceted approach in efforts to develop clinical trials with biologic and pharmacologic rationale and included a) experimental therapeutics and noninvasive analysis of individual patients, including multiparametric imaging, b) utilization of preclinical models to study CNS pharmacology of agents and alternate delivery methods, and c) study of tumor biology to identify potentially druggable targets.

Areas of Expertise

1) brain tumors, 2) pediatric clinical trials, 3) diffuse intrinsic pontine glioma (DIPG),
4) drug delivery, 5) multiparametric imaging, 6) pharmacokinetics

Contact Info

Katherine E. Warren, M.D.
Center for Cancer Research
National Cancer Institute
Building 10 - Hatfield CRC, Room 1-5750
Bethesda, MD 20892-1104
Ph: 240-760-6202

Pediatric Neuro-Oncology Section

Pediatric brain tumors represent a heterogeneous group of diseases. A significant proportion of tumors are considered benign or low-grade. The 5-year survival for these children is currently over 70%.

However, for those children with malignant tumors including diffuse intrinsic brainstem gliomas and high-grade gliomas and those with recurrent malignant tumors, the 5-year survival is dismal. Despite neurosurgical and radiotherapeutic advances, no significant improvement in survival has been made for patients suffering from these tumors in several decades.

The armamentarium for the treatment of pediatric central nervous system (CNS) tumors includes surgery, radiation and chemotherapy. Although surgery may be curative for focal, benign tumors, adjuvant therapy is necessary for invasive, malignant lesions. Radiation therapy is toxic to the developing brain and avoided or deferred if possible, in very young children. Although chemotherapy plays an important role, improvement in the survival of pediatric patients with malignant gliomas and recurrent malignant tumors, has been modest, at best, and for some tumors, such as diffuse intrinsic pontine gliomas, no chemotherapy has ever demonstrated an ability to improve patient outcome. Few agents are available for clinical development in children.

In addition to the sometimes disparate tolerability and pharmacokinetics between adult and pediatric patients, pediatric CNS tumors differ from adult CNS tumors in histology, biology, pathophysiology and location, and therefore efficacy data available for adults may not apply to pediatric patients. Rational drug development based on relevant pharmacokinetics (PK), such as CNS penetration, is infrequently performed, and early studies instead frequently aim to identify a maximum tolerated dose rather than a targeted effective dose.

The major goals of the Pediatric Neuro-Oncology Section are rational, PK-based, drug development in the pediatric population, and investigation of novel therapeutic approaches, such as convection-enhanced delivery. Assessing tumor characteristics and treatment effects noninvasively is particularly important in pediatric neuro-oncology given the technical and ethical limitations of repeat tissue sampling in these children. Defining and incorporating innovative endpoints in clinical trials designed to determine the biologic and therapeutic activity of new agents is a major focus of our research.

NIH Scientific Focus Areas:
Cancer Biology, Clinical Research, Neuroscience
View Dr. Warren's PubMed Summary.

Selected Key Publications

  1. Warren KE, Patronas N, Aikin AA, Albert PS, Balis FM.
    J Natl Cancer Inst. 93: 1401-5, 2001. [ Journal Article ]
  2. Lonser RR, Warren KE, Butman JA, Quezado Z, Robison RA, Walbridge S, Schiffman R, Merrill M, Walker ML, Park DM, Croteau D, Brady RO, Oldfield EH.
    J. Neurosurg. 107: 190-7, 2007. [ Journal Article ]
  3. Hipp SJ, Steffen-Smith E, Hammoud D, Shih JH, Bent R, Warren KE.
    Neuro-oncology. 13: 904-9, 2011. [ Journal Article ]
  4. Warren KE, Killian K, Suuriniemi M, Wang Y, Quezado M, Meltzer PS.
    Neuro-oncology. 14: 326-32, 2012. [ Journal Article ]
  5. Fangusaro J, Warren KE.
    J. Neurooncol. 113: 341-2, 2013. [ Journal Article ]

Dr. Warren received her B.S. in Medical Technology in 1982 and her M.D. from Tufts University School of Medicine in 1990. She completed a residency in pediatrics at Children's National Medical Center, followed by a fellowship in pediatric oncology at the National Cancer Institute. She is board certified in pediatrics and pediatric hematology/oncology. Dr. Warren was a Senior Investigator in the Pediatric Oncology Branch specializing in neuro-oncology. Her research interests include performance of clinical trials, particularly in children with tumors of the central nervous system, non-invasive evaluation/imaging of the brain, and neurotoxicity resulting from tumors and their treatment. She departed NCI in 2019 and is currenty a special volunteer.

Name Position
Rafael Cruz Garcia Biologist (Contr.)
Cindy Lester McCully B.S. Biologist
Priya Shankarappa Postbaccalaureate Fellow (CRTA)
Kim Walker R.N. Research Nurse