Tuesday, July 29, 2014

Phase 3 trial on aldoxorubicin raises hopes

By Suzie Siegel

Imagine a drug that would be just as effective as Adriamycin (doxorubicin) but could be taken longer, without damaging your heart. That's the dream of aldoxorubicin, which is in a Phase 3 clinical trial for soft-tissue sarcoma in the U.S. and Europe.

Stephanie Zimmerman, MSN
Stephanie Zimmerman of Atlanta shares this dream. At age 8, she was given doxorubicin and underwent chest radiation to cure her of Ewing's sarcoma. Three decades later, her heart failed and she had to have a transplant.

"I look forward to the day that a less cardiotoxic chemotherapeutic agent such as aldoxorubicin is made widely available to adults and children alike," said Zimmerman, president and co-founder of myHeart, yourHands, a nonprofit that raises awareness about late effects of cancer treatment, raises money for research and supports survivors. She has a master's degree in nursing and worked in pediatric oncology before her heart problems.

"No one should be cured of cancer only to lose their hearts, their lives, to a life-threatening late effect such as heart failure. The preliminary findings on aldoxorubicin are encouraging, and oh, how I hope, the clinical trial continues to be promising."

CytRx Corp. of Los Angeles is developing the drug, which is designed to deliver doxorubicin directly into a tumor, leaving healthy tissue unharmed.

Sant Chawla, MD
"We are excited about the potential for aldoxorubicin to safely treat patients with relapsed or refractory soft-tissues sarcomas, many of whom have received and failed to respond to prior doxorubicin therapy," said Sant Chawla, MD, the principal investigator of the trial. "Because of the cardiac safety profile of aldoxorubicin, the FDA is allowing us to treat patients who have received up to 375 mg/m2 of prior doxorubicin, and we can treat until tumor progression is observed." 

Dr. Chawla, director of the Sarcoma Oncology Center in Santa Monica, Calif., has much experience running clinical trials.

"This 100-center, international trial is the first that allows the use of the investigator’s choice of standard soft-tissue sarcoma drugs in the control arm, a situation that should allow rapid recruitment to the study.” In the randomized trial, doctors can choose to compare the drug to doxorubicin, dacarbazine, pazopanib, gemcitabine + docetaxel, or ifosfamide. For more information, go to ClinicalTrials.gov.

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