MAJOR ONGOING INITIATIVES

Pediatric Clinical Trials Cooperative Groups and Consortia

http://ctep.cancer.gov/industryCollaborations/default.htm#initiatives

• The Children’s Oncology Group
• COG Phase 1/Pilot Consortium
• New Approaches to Neuroblastoma Therapy Consortium
• Pediatric Brain Tumor Consortium
• Pediatric Preclinical Testing Program

CTEP-sponsored pediatric trials are conducted primarily by the Children’s Oncology Group (COG), its Phase 1 Consortium, the Pediatric Oncology Branch of the NCI Center for Cancer Research (CCR), the New Approaches to Neuroblastoma Therapy (NANT) Consortium, and the Pediatric Brain Tumor Consortium. CTEP also supports a limited number of pediatric clinical trials through P01 program project grants and through the conventional NCI investigator-initiated research funding mechanisms, such as R01s.

• The Children’s Oncology Group The Children’s Oncology Group (COG) is supported by CTEP and conducts clinical trials devoted exclusively to children, adolescents, and young adults with cancer. It develops and coordinates cancer clinical trials at more than 200 member institutions, which include cancer centers of all major universities and teaching hospitals throughout the United States and Canada, as well as sites in Europe and Australia. COG members include more than 5,000 cancer researchers dedicated to saving the lives of children with cancer. Through the COG network of member institutions, children with cancer, regardless of where they live, can access state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists.

• COG Phase 1/Pilot Consortium
  The COG Phase 1/Pilot Consortium’s primary objective is to expeditiously develop and implement pediatric phase 1 and pilot studies, thus facilitating the integration of advances in cancer biology and therapy into the treatment of childhood cancer. The consortium includes approximately 20 institutions. Pharmacokinetic and biological correlative studies are key components of the consortium’s phase 1 trials and are increasingly important for new agents with specific molecular targets. The consortium conducts pilot studies of promising multi-agent regimens. These studies are an important step in the integration of new agents into the therapy of specific childhood cancers and require careful monitoring for toxicity and safety. After their initial evaluation for safety in children by the consortium, agents and regimens can be studied within the larger group of COG institutions to determine their role in the treatment of specific childhood cancers.

• New Approaches to Neuroblastoma Therapy Consortium
  This New Approaches to Neuroblastoma Therapy (NANT) Consortium brings together university and children’s hospitals to test promising new therapies and combination therapies for high-risk neuroblastoma. The group is closely linked with laboratory programs developing novel therapies for high-risk neuroblastoma. The group conducts early- phase clinical trials, with the goal that promising therapies identified in these trials will be tested nationally through COG.

• Pediatric Brain Tumor Consortium
  The primary objective of the Pediatric Brain Tumor Consortium (PBTC) is to rapidly conduct phase 1 and 2 clinical evaluations of new therapeutic drugs, intrathecal agents, delivery technologies, biological therapies, and radiation treatment strategies for children 0–21 years of age with primary central nervous system tumors. The PBTC consists of nine leading academic institutions that have extensive experience with tumors of the brain that develop during childhood. Another objective of the PBTC is to develop and coordinate innovative neuroimaging techniques.

• Pediatric Preclinical Testing Program
  The Pediatric Preclinical Testing Program (PPTP) systematically evaluates novel agents against pediatric preclinical models to develop datasets that can assist clinical researchers in selecting study agents and combination therapies that are most likely to be effective for childhood solid tumors and leukemias. Some correlations have been observed between preclinical antitumor activity of agents tested in pediatric tumor models and clinical activity of these same agents. Although these examples support the potential predictive value of preclinical models, validation of the models across a broader range of pediatric cancers and therapeutic agents is needed. Since 2005, more than 50 agents or combinations of agents have been tested against PPTP’s molecularly characterized panel of childhood cancers.