A dedicated space for cancer patients volunteering to be part of first-phase clinical drug studies has opened at the Seattle Cancer Care Alliance. The phase 1 Clinical Trials Unit is the Pacific Northwest’s first such academic-based program and serves the Fred Hutchinson/University of Washington Cancer Consortium.
“Our dedicated phase 1 clinical research study unit will provide earlier access to promising new drugs for SCCA patients,” said Dr. John Thompson, director of the unit and co-director of the SCCA’s melanoma clinic. With new space and staff, the unit significant expands the SCCA’s existing phase 1 studies program.
Phase 1 trials: 'The go or no point'
Phase 1 testing represents a key decision point in a drug’s development. “We take this responsibility seriously because each drug that gets to phase 1 trials has already gone through extensive and expensive development,” Thompson said. “It’s the ‘go’ or ‘no go’ point. If we uncover significant problems, the drug’s development could be halted. Or it may suggest that the drug could be modified. The drug won’t go into phase 2 trials without a robust phase 1 study.”
If the results of phase 1 testing are encouraging, a drug may move to phase 2 studies, in which the drug is tested in a larger number of patients with a given cancer, to determine the activity of the drug in that disease. Phase 3 trials then test the experimental drug against the current standard to compare activity and side effects.
For one of Thompson’s patients, Tom Vanderhoeven, participation in an early stage study represents more than volunteering to help advance science. The experimental drug therapy he receives is the only treatment currently available to battle Vanderhoeven’s metastatic melanoma. Many patients enroll in early phase studies for this reason.
A specialized unit with physical space and staff dedicated to phase 1 studies is important because this type of research is very labor intensive for staff and patients, Thompson said. “Patients receive various doses of the drug and they have to be monitored, sometimes for extensive periods of time, to record and manage potential side effects. Patients must have frequent and precisely timed blood draws to measure the amount of drug in the bloodstream.”
New unit location, funding
The new unit, located on the SCCA’s fifth floor, operates five days a week and includes a nursing station, space for research coordinators, and four rooms where research subjects receive medications and undergo blood draws and other tests. After patients finish the drug treatment and initial tests, they move to an adjacent open monitoring space for additional blood tests and monitoring for side effects.
Start-up funding to cover personnel costs for the new unit came from a three-year, $2.1 million grant from the state of Washington’s Life Sciences Discovery Fund. The SCCA paid construction costs.