GCCRI Xenograft/Cell Lines Core Form

GCCRI Xenograft/Cell Lines Core
Tumor Panel
Will statistical analysis be requested?
(This section should provide the rationale supporting prioritizing the proposed agent for evaluation by the GCCRI PDX Core. The areas that should be addressed are outlined at the end of this document. Limit to no more than 1 page.)
(Succinctly state the hypothesis that is the basis for the request for testing of the proposed agent.)
(Succinctly describe the testing that is requested, including the agent(s), schedule, models to be tested, and whether any pharmacodynamic/pharmacokinetic or toxicity testing is requested. Limit to one page.)
(Describe any resources that the applicant is able to support with non-GCCRI PDX Core resources to enrich the proposed testing. Examples include pharmacokinetic analysis, testing of tissues for specific biomarkers, etc. Limit to one page.)

Agent Proposals should be submitted to the GCCRI PDX Core (Attn. Dr. Raushan Kurmasheva) via e-mail at: Kurmasheva@uthscsa.edu

Topics to address in the Background and Rationale Section include:

  • Background Information: sufficient information to identify and clarify the scientific and medical context from which the opportunity emerges.
  • Preclinical molecular target (mechanism of action): Sufficient information should be provided to document the degree of specificity of the agent for its claimed molecular target(s) or mechanism of action. The known or potential relevance of the agent’s target or mechanism of action to childhood cancers should be summarized.)
  • Preclinical in Vitro Studies: Summary of data from both single agent in vitro studies and combination in vitro studies, if performed, should be provided.
  • Preclinical in Vivo Studies: Summary of data concerning the in vivo anticancer activity of the agent should be summarized. In general, appropriate agent administration schedules for demonstrating anti-cancer activity and the maximum tolerated doses for these schedules should be known at the time that an agent is proposed for pediatric preclinical testing. For most agents, these data will likely be primarily taken from adult cancer preclinical models, but data from pediatric models should be provided as well when available.
  • Preclinical Pharmacokinetics (when available): Of particular interest is the availability of pharmacokinetic data from preclinical models used to demonstrate efficacy.
  • Status of Clinical Development: Priority is given to studying agents that are entering (or have entered) clinical evaluation. Information concerning the current status of clinical development of the agent should be provided, along with any plans for potential pediatric evaluations of the agent.