The clinical research for developing
more effective treatments for cancer

Faculty Fellowship in Pediatric Oncology Clinical Research

January 09, 2007
by Akane Naka, Project Manager


The Texas Children's Cancer Center combines the strengths of Texas Children's Hospital and Baylor College of Medicine (BCM), both of which are located in Houston. Texas Children's Hospital is the largest freestanding pediatric facility in the United States; an internationally recognized, licensed 639-bed, full-care pediatric hospital located in the Texas Medical Center; the pediatric teaching hospital of BCM; and home to the College's full-time pediatric faculty. BCM is ranked in the top 10% in federal research funding among medical schools in the U.S. Physician-scientists on the BCM faculty who provide patient care at Texas Children's Cancer Center, are at the forefront of medical research. This means our patients have the distinct advantage of receiving the most advanced, state-of-the-art medical treatments from highly skilled pediatric cancer treatment experts.

Pediatric Oncology Clinical Research

The Faculty Fellowship in Pediatric Oncology Clinical Research provides a formal, comprehensive, multidisciplinary clinical research educational program to teach pediatric oncologists and Ph.D. prepared oncology nurses the design, implementation and analysis of all phases of clinical research trials. This is a structured program in which trainees receive in-depth education through a core clinical research curriculum and participation in clinical research training in one of five specialized training tracks: clinical pharmacology, neuro-oncology, cell and gene therapy, leukemia or solid tumor.

These specialized areas have been purposely chosen for two reasons. First, within Texas Children's Cancer Center, they represent funded programs of significant research strength, each with strong collaborative interactions between basic and clinical scientists. Second, within the field of pediatric oncology, they represent five critical areas in which clinical research success must occur for continued progress against childhood cancer to be realized.

Purpose & Objectives
two to three year formal, comprehensive, multidisciplinary clinical research educational program for M.D.s and Ph.D.-prepared oncology nurses focusing on the design, implementation and analysis of all phases of clinical research trials. Trainees will receive in-depth education through a core clinical research curriculum (through the Clinical Scientist Training Program) and participation in clinical research training in one of five specialized training tracks:

Clinical Pharmacology Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on the design, proper conduct, and analysis of phase I and II pharmacokinetic studies of new anticancer agents.
* To develop proficiency in laboratory and data analysis skills as they pertain to pharmacokinetic and other correlative studies.
* To develop expertise in the special requirements of clinical and pharmacologic studies of new anticancer agents in infants, children and adolescents.
* To acquire in-depth knowledge of the basic principles of the pharmacology of anticancer drugs.
* To interact with COG, pharmaceutical companies, and regulatory bodies in order to acquire an understanding of the roles of national organizations, cooperative groups, sponsors, regulatory bodies, and clinicians during the drug development process.
* To understand the ethical and regulatory issues involved in pediatric drug research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Neuro-Oncology Clinical Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on the design and proper conduct of phase I, II, and III clinical studies as they pertain to children with CNS tumors.
* To develop expertise in the fundamentals of treatment for CNS tumors.
* To develop an understanding of the molecular events involved in the development of CNS neoplasms.
* To gain expertise in the development of correlative studies that incorporate new diagnostic technologies, neuroimaging techniques, and treatment modalities.
* To understand the ethical and regulatory issues involved in pediatric clinical research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Cell and Gene Therapy Clinical Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on gene identification, expression and regulation, and target cell identification.
* To examine methods for gene delivery, including retroviral, lentiviral, adenoviral, other DNA viruses, and non-viral vectors.
* To review tissue-specific perspectives for gene delivery.
* To understand the specifics of cancer gene therapy.
* To evaluate the essential components related to vaccine therapy.
* To examine the use of gene therapy through the use of bone marrow and stem cells.
* To review specific regulatory and ethical considerations related to cell and gene therapy.

Leukemia Clinical Research Track Objectives:
* To develop expertise in the design and implementation of clinical research trials for children with acute and chronic leukemias, including diagnosis, therapy, and management of acute and chronic complications and care of long-term survivors.
* To develop proficiency in laboratory skills and data analysis as they pertain to treatment of children with leukemia.
* To develop expertise in the special requirements of clinical and pharmacologic studies of new anticancer agents for the treatment of leukemia.
* To interact with COG in order to understand the development of multi-institutional clinical trials in leukemia.
* To explore clinically applicable laboratory research in areas pertinent to leukemia.
* To understand the ethical and regulatory issues involved in leukemia biology research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Solid Tumor Clinical Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on the design and proper conduct of phase I, II, and III clinical studies as they pertain to children with solid tumors.
* To develop expertise in the fundamentals of the treatment of solid tumors.
* To develop knowledge regarding a current understanding of the molecular events involved in the development of solid tumors.
* To gain expertise in the development of correlative studies that incorporate new diagnostic technologies, neuroimaging techniques, and treatment modalities.
* To understand the ethical and regulatory issues involved in research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Eligibility
Trainees will be:
Fully trained pediatricians who have completed a three-year pediatric hematology-oncology fellowship training program and are board eligible in that subspecialty, and Ph.D. nurses with a career interest in pediatric oncology clinical research.

All candidates must be citizens or non-citizen nationals of the United States, or be lawfully admitted to the U.S. for permanent residence.

More information:
Mentorship
Application Criteria

This article is reposted with thanks to Texas Children's Cancer Center Hematology Service.