This study is investigating the best dose and effectiveness of brentuximab vedotin (Adcetris) combined with ICE (ifosfamide, carboplatin, etoposide) for Hodgkin’s lymphoma (HL) patients with relapsed or refractory (not responding to treatment) disease. The main outcomes to be measured include the tolerated dose without unacceptable side effects and response to treatment. This study is being conducted in Seattle, Washington.
The details
Brentuximab vedotin is a monoclonal antibody. This type of treatment binds to cancer cells and stops them from dividing. ICE chemotherapy damages the DNA inside cancer cells. This leads to cancer cell death. Giving brentuximab vedotin together with the ICE chemotherapy regimen (BV-ICE) may kill more cancer cells than either treatment alone.
This study is investigating the best dose and effectiveness of brentuximab vedotin that can be combined with ICE chemotherapy. Side effects, progression-free survival (time from study treatment before disease progression) and overall survival (time from study treatment until death from any cause) rates at 5 years are used to determine effectiveness.
Who are they looking for?
This study is recruiting 42 patients. To participate in this study, patients must have first-time refractory or relapsed disease and expect to finish the study treatment. Platelet levels must be 100,000/uL or higher. Serum creatinine levels must be less than 1.5 mg/dl. Total bilirubin must be less than 2 times the highest normal level. Aspartate aminotransferase levels must be less than 2.5 times the highest normal level.
Patients who are HIV positive or are pregnant or nursing cannot participate in this study. Patients who are allergic or intolerant or have disease that is resistant to ICE chemotherapy cannot participate. Patients who received brentuximab vedotin or pelvic radiation within a year cannot participate. Patients who received any other chemotherapy or immunotherapy within 3 weeks cannot participate.
How will it work
Patients receive brentuximab vedotin and ICE chemotherapy over the course of three days. Brentuximab vedotin is given on the first day of treatment. Ifosfamide (Ifex) and carboplatin (Paraplatin) are given on the second day. Etoposide (Toposar) is given on all three days. This treatment is repeated every 21 days for a total of two cycles.
Patients are followed up every 3 months for 1 year, and then every 6 months for 4 years. The best dose of brentuximab vedotin is determined 28 days after the last dose. The number of patients who show complete remission (complete disappearance of all signs of cancer) is determined three weeks after the end of treatment.
