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Using CBL0137 To Treat Patients With Advanced Extremity Melanoma or Sarcoma


A central question in oncology is how to offer efficacious treatments while minimizing toxicity. This is especially true when treating advanced sarcoma and melanoma of the extremity.

Traditional regional therapy — isolated limb perfusion and infusion — isolates blood circulation to the afflicted extremity and delivers high doses of chemotherapy to the area. While this can be curative in certain situations, the treatment is old: It was developed in the 1950s, and it uses a very toxic chemotherapy.

Joseph Skitzki, MD, FACS, Associate Professor of Oncology and Chair of the Melanoma/Sarcoma Disease Site Research Group at Roswell Park Comprehensive Cancer Center, is leading an exciting clinical trial designed to provide an alternative: a low-toxicity, potentially limb-saving treatment that is just as effective as traditional chemotherapy against sarcoma and melanoma.

The trial involves CBL0137, a novel agent developed at Roswell Park by Andrei Gudkov, PhD, DSci, and Katerina Gurova, MD, PhD. “In preliminary studies, CBL0137 seems to be very efficacious,” says Dr. Skitzki. “It actually seems to be as efficacious as standard chemotherapy, but lacks the toxicity.”

The rationale behind using CBL0137 for extremity melanoma and sarcoma is that advanced-stage extremity tumors are very difficult to treat. In some cases, the tumor is resistant to standard therapies, leaving limb amputation as the only viable option. This clinical trial is designed as a way to potentially avoid amputation.

“This new approach changes the paradigm of regional therapies for cancer, making it much easier to deliver and potentially much less toxic,” Dr. Skitzki explains. “The clinical trial involves a 15-minute intra-arterial infusion of CBL0137. It appears to be well tolerated and much less toxic than standard chemotherapy options. Patients treated on this trial seem to have done very well.”

The phase I clinical trial is currently open at Roswell Park Comprehensive Cancer Center for patients who have extremity melanoma or sarcoma. To learn more, contact Roswell Park at or connect with Dr. Skitzki at

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