FRIDAY, SEPTEMBER 30, 2016

Phase 3 of sarcoma chemotherapy trial is discontinued

The trial started in October 2013 and involved 184 men and women from six different countries in Africa and South America. | File photo

A clinical trial designed to compare three advanced Kaposi’s sarcoma chemotherapy treatment regimens combined with antiretroviral treatment (ART) for AIDS patients will not accept any more participants into its oral chemotherapy drug etoposide tests.

The randomized, Phase 3 trial that received funds from the National Institute of Allergy and Infectious Diseases (NIAID) has discontinued its entire oral chemotherapy drug etoposide study arm. This is because the drug under-performed. In contrast, the chemotherapy drug paclitaxel combined with ART.

As of today, there have not been any safety concerns identified within the three investigational treatments.

The trial started in October 2013 and involved 184 men and women from six different countries in Africa and South America. The goal was to determine the clinical efficiency of two different treatment regimens: oral etoposide with ART and intravenously delivered bleomycin and vincristine (BV) with ART combined with intravenous paclitaxel with ART. These both were tested for advanced stage AIDS-Kaposi’s sarcoma.

The trial’s oral strategy would have provided a more flexible approach for treating sarcoma in places where there is unreliable or unsupported health care infrastructure for intravenous chemotherapy.

The NIAID held a data and safety monitoring board meeting to discontinue the etoposide portion of the trial on March 10. The meeting included statisticians, clinical research experts, community representatives and ethicists.

Organizations in this story

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, MSC 9806 Bethesda, MD 20892-9806

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