The Sunshine Project

Mission:
The purpose of The Sunshine Project is to utilize a novel collaborative approach that accelerates the development of new drugs and therapies leading to the prevention and cure of pediatric cancers.

Overview
Pediatric cancer remains the number one killing disease of our children. The Pediatric Cancer Foundation decided to aggressively pursue measurable change in the way pediatric cancer research is approached and funded through the launch of The Sunshine Project.

Through this collaboration, we have brought together some of the country’s leading investigators and institutions to drive the process of finding a cure.

Initially targeting solid tumors, The Sunshine Project employs a unique approach that simultaneously introduces newly developed and potentially life-saving drugs to children with cancer around the country, while conducting vital research that provides investigators with key insights into the disease itself to determine why the drugs are effective.

The Sunshine Project is comprised of three crucial research elements – Translational Research, Clinical Trials and Basic Science.

Translational Research
Historically, pharmaceutical companies that have developed a potential new drug will approach a research institution to conduct translational research and clinical trials. The pharmaceutical company will fund the research and trials in hopes that the drug will be effective and eventually approved for use by the FDA.

Because pediatric cancers are considered rare as compared to adult cancers, the market potential for a new drug is very small, and very few drug companies actively seek clinical trials for childhood cancer drugs. A government report in April found a “near absence” of research into pediatric cancer drugs. According to a report by the Institute of Medicine, a non-profit group that advises the government on health policy, approximately half of the oncology drugs to treat children are at least 20 years old. Additionally, pharmaceutical companies do not test their drugs on pediatric cancers because they run a risk of failure with a drug that has been effective in the more lucrative adult market.

Translational Research is a phase of drug development where multi cell lines of tumors are tested in a laboratory setting with new drugs. This research element allows investigators to determine whether a drug has potential use against a particular type of tumor. The Sunshine Project team actively pursues possible drugs to determine their potential with solid tumors. With this mechanism we drive the research and cure process.

Clinical Trials
Once a drug has illustrated potential against a particular tumor, a clinical trial is written for presentation to the project’s designated Phase I Consortium, which is comprised of the nation’s leaders in pediatric oncology. With a successful Phase I clinical trial complete, we implement Phase II and III Clinical Trials through our network of partnering national institutions.

In The Sunshine Project’s clinical trials, we target pediatric patients who have received the standard protocol for their initial diagnosis and then had metastasis of the disease. Unfortunately for these children, once the tumor has metastasized, there are currently no other standard effective protocols for the treatment of the disease. By giving these patients the option to participate in new clinical trials, we will also give them new hope.

Basic Science
Once we have learned that a drug has promise in the laboratory and a Phase I clinical trial is being initiated, we then have to learn why that drug is effective. In researching why the drug is working, we hope to learn how it may be effective on other types of cancers or diseases. We conduct molecular studies using microarray analysis of each tumor specimen. This helps us learn, at a rapid pace, what other drugs may have potential fighting the disease and what drugs we can eliminate. We will also begin to see similarities and differences among the different tumors which will help us further understand the disease and potential treatments.

Additionally, by simultaneously conducting the Basic Science portion of our project and Clinical Trials, we expedite the oftentimes long process of federal drug approval. The completion of clinical trials and basic science research allows us to accelerate FDA approval and provide pediatric cancer patients with a new and promising treatment option.

The collaborative effort that is employed through The Sunshine Project is extraordinarily rare in the world of research, particularly in the arena of pediatric oncology. The Sunshine Project is executed at a rapid rate and relies on the cooperative efforts of several investigators from numerous leading institutions and requires the support of many. Through this novel approach, the Pediatric Cancer Foundation is literally changing the way research is done.