This phase 1/2 clinical trial will test the safety and effectiveness of brentuximab vedotin (SGN-35) in treating HIV-associated Hodgkin’s lymphoma. The primary outcome will be measured by the maximum tolerated dose (due to side effects) and the time to disease progression.
The details
Brentuximab vedotin is a therapy that uses an antibody (a protein in the immune system) to deliver an attached drug to cancerous lymphocytes (type of white blood cell). The antibody is designed to bind to a protein called CD30 that is often found on the surface of Hodgkin’s lymphoma cells. Once bound, the antibody will be taken into the cancer cell where the drug will be released, resulting in cell death. Combining this targeted therapy with a less specific combination chemotherapy may kill more cancer cells.
This study will examine the effectiveness of brentuximab vedotin in combination with chemotherapy in patients with HIV-associated Hodgkin lymphoma. The study will examine the maximum tolerated dose of the therapy for 28 days, and the time until disease progression over 2 years. The response to the treatment, survival rate, and negative events will also be observed.
Who are they looking for?
This trial is recruiting 70 patients who have Hodgkin lymphoma and are HIV positive. Patients should not have received prior anthracycline therapy (a type of chemotherapy such as daunorubicin). Those with a history of prior cancers should be disease free for at least 5 years. Participants being treated with antivirals containing zidovudine (such as Combivir) or ritonavir (such as Norvir) must change to a different treatment at least 7 days before entering the study.
Participants must be able to tolerate chemotherapy. Those with conditions such as kidney failure, recent heart attack, or uncontrolled infection will be excluded.
How will it work
Patients will receive a combination chemotherapy and brentuximabintravenously (through IV into a vein) on days 1 and 15 of a 28-day cycle. Treatment will continue for up to 6 cycles as long as there is no evidence of disease progression or unacceptable side effects.
