Cincinnati Children’s pediatric oncologists James Geller, MD, and Maureen O’Brien, MD, MS, are providing critical leadership within Children’s Oncology Group (COG) that will help establish standards of care for renal tumors and blood cancers for the next decade.

James Geller, MD

Geller is the new chair of the COG’s Renal Tumor Committee, which oversees three open protocols and has three more under development. Geller, who is director of the Liver, Kidney and Retinoblastoma Programs at Cincinnati Children’s, is the national principal investigator for two of the open studies. One is investigating how well combination chemotherapy works in treating high-risk Wilms tumors (AREN1921) and the other (AREN1721) is focused on immunotherapy and anti-angiogenic therapy for patients with translocation renal cell carcinoma (tRCC). Combined, they include patients from more than 200 hospitals nationwide.

Geller’s commitment to finding new, more effective therapies for renal cancer is long-standing. He has served on the COG’s Renal Tumor Developmental Therapeutics Committee for the last 15 years and is the COG lead for Harmonica, a joint initiative with the International Society of Pediatric Oncology Renal Tumor Study Group to advance clinical effectiveness research.

Geller and colleagues at Cincinnati Children’s provide leadership in pediatric liver research as well. He and Pediatric Surgery Division Director Greg Tiao, MD, are international co-chairs of AHEP1531, the COG/international study of hepatoblastoma and hepatocellular carcinoma in children and adolescents. AHEP1531 is the only front-line pediatric liver tumor protocol open in the United States and is a significant undertaking, with a recruitment goal of 1,200 patients. More than 300 patients have enrolled through COG since the study began in 2018.

“International collaboration is essential in our efforts to find new therapies for rare, high-risk cancers,” Geller says. “COG provides critical leadership, and I am excited about the work we do with pediatric oncologists, pathologists, surgeons, statisticians and others around the world.”

Maureen O’Brien, MD, MS

O’Brien, who is director of the Leukemia/Lymphoma Program at Cincinnati Children’s, is the national co-principal investigator for a Children’s Oncology Group Phase 3 study (AALL1732) evaluating a novel combination therapy for patients with newly diagnosed high-risk B-cell acute lymphoblastic leukemia (B-ALL). This randomized study is evaluating the effectiveness of adding 2 cycles of the novel antibody-drug conjugate inotuzumab ozogamicin (InO) to the standard chemotherapy backbone compared to the chemotherapy backbone alone. This is also the first trial to track the outcomes of subjects with advanced stage B-LLy or MPAL who are treated with B-ALL chemotherapy.

The study is expected to enroll about 3,700 patients ages 1-25 years at 213 cancer centers in the US, Canada, Australia, and New Zealand over the next four years, including 2,084 randomized patients with B-ALL. Recent trials that increased the intensify of standard cytotoxic chemotherapy have failed due to toxicity, but InO has a favorable side effect profile and is an ideal agent to study.

“The primary aim is to understand whether adding InO to standard of care chemotherapy is safe and improves outcomes in newly diagnosed high-risk B-ALL,” O’Brien says. “We have found in an ongoing study for patients with relapsed B-ALL that InO is very effective and well-tolerated, so the goal of this large, randomized trial is to move this agent to frontline therapy in the hopes of preventing patients from ever experiencing relapse. In addition, we are also studying whether treating both males and females for two-and-a-half years maintains outcomes for males, who have previously been treated for an additional year compared to girls. Lastly, we plan to evaluate the best ways to help patients adhere to oral chemotherapy regimens.”

Cincinnati Children’s offers a wide portfolio of experimental therapies for patients with high-risk leukemia, including an array of next-generation targeted drugs, immunotherapies and novel bone marrow transplant approaches.

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