Doc Restrepo called me yesterday to let me know Seattle Genetics has opened a clinical trial for their new drug SGN-35 (Brentuximab Vedotin) that I qualify for. This is a phase I trail for evaluating the safety of SGN-35 combined with ABVD for HL treatment. SGN-35 will be administered at 0.6-1.2 mg/kg with each ABVD treatment.
SGN-35 is an antibody-drug conjugate targeted to CD30 (that’s the bad guy we want to whack). Results have been published from two SGN-35 trails: one for relapsed and refractory (disease that resists treatment) HL patients, and the other for Anaplastic Large-cell Lymphoma (ALCL, a type of non-Hodgkin’s Lymphoma). In both trials SGN-35 was used alone not in conjunction with chemotherapy.
In the HL trial 75% of 102 patients achieved an objective response (complete or partial remission), as assessed by an independent review. 34% of patients achieved full remission. Tumor reductions were achieved in 94% of patients. 18 patients discontinued this trial due to adverse events. To qualify for this trail patients must have previously received an autologous stem cell transplant (ASCT, that means they collect your own stem cells before a chemotherapy regimen kills your immune system then transplant the collected stem cells to re-grow the bone marrow). The median number of previous chemotherapy regimens for patients in this trail was 4 (range 1-13).
The ALCL trial included 58 patients. All patients had previously received front line treatments. SGN-35 was administered alone once every 21 days by IV (1.8mg/kg). 86% of patients achieved an objective response to the drug. 53% achieved complete remission. The most common adverse events were nausea (38%), peripheral neuropathy (38% - numbing of the fingers and the toes), fatigue (34%), fever (33%) and diarrhea (29%).
If I decide to join the trail I will have to get several blood test and scans (CT and PET). This will delay the start of treatment by about two weeks. Doc Restrepo feels that given the positive response to the Prednisone and Cyclophosphamide I was on delaying treatment will not adversely affect prognosis. While taking the drugs all of my b-symptoms were relieved but since completing the cycle I have experienced some fatigue and discomfort in my neck. Both are very minor compared to before the drugs but I am concerned that will change inside of three weeks. I cannot take the Prednisone or Cyclophosphamide in the interim due to the side effects, and as a result I risk the disease progressing in the interim.
