Partnership Brings Clinical Trials to Communities

The Leukemia & Lymphoma Society (LLS) of White Plains, NY, and Dana-Farber Cancer Institute (DFCI) in Boston, MA, have formed the Blood Cancer Research Partnership (BCRP) to bring innovative clinical trials to community practices. The goals are to speed the translation of laboratory work into clinical trials and to hasten the development of new drugs, according to LLS Chief Mission Officer Louis DeGennaro, PhD.

Because numerous, often rare, subtypes of blood cancer exist, finding enough participants to fill a trial can be challenging—meaning fewer trials for blood cancers than for solid cancers. As a result, DFCI proposed the program, which will focus on studies of hematologic malignancies, says Irene Ghobrial, MD. A medical oncologist in the Division of Hematologic Malignancies at DFCI, Ghobrial codirects the BCRP with Robert Soiffer, MD, chief of DFCI's Division of Hematologic Malignancies.

Up to 80% of cancer patients receive treatment from community-based oncologists and cannot participate in clinical trials, which are usually conducted at urban hospitals, research institutes, and academic medical centers, because of travel logistics. “Community oncologists have felt a huge need for innovative clinical trials to be opened at the sites where their patients are located,” Ghobrial says.

A major challenge with any clinical trial is accruing enough patients. “If we bring clinical trials to the patient, we believe we can speed the rate of accrual, make the process more efficient, and test more therapies,” DeGennaro explains.

Patients will benefit from the BCRP as well, gaining access to promising treatments that are available only through clinical trials.

The LLS is investing $1,050,000 in the 3-year project, which will fund research in 11 states: California, Colorado, Florida, Georgia, Illinois, Kansas, New Jersey, New York, Tennessee, Texas, and Washington.

Ghobrial says the BCRP will initiate phase I or II studies—based on scientific evidence from DFCI labs—with the potential to have a large impact on the practice of medicine.

The first three planned trials will involve

• testing TH-302 (Threshold Pharmaceuticals), a prodrug that releases the cytotoxic DNA crosslinking agent bromo-isophosphoramide mustard when exposed to hypoxic conditions, in patients with multiple myeloma;

• looking for a circulating DNA biomarker to detect minimal residual disease in lymphoma; and

• assessing the ability of the CTLA-4 inhibitor ipilimumab (Yervoy; Bristol-Myers Squibb) to enhance immune reactivity in patients whose hematologic disease has recurred after stem cell transplant.

The major criteria for success will be how fast the trials open, how many patients are enrolled, and how efficiently the trials proceed. The researchers anticipate that trials should open and close within roughly 18 months, with sites enrolling two to three patients in each trial.

At the end of the 3 years, Ghobrial and Soiffer hope the early-phase research will have advanced to larger phase III trials—and that the kernel of this interaction between academic and community centers will take root, leading to more trials for more cancers.