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.
Hi Merch, A good friend of mine was told that SGN-35 is her last option. Having trouble however, accessing it in Canada. Is this trial being run out of Vancouver? If so, can you provide me with any info/contacts?
ReplyDeleteAny info is really appreciated.
Sylvia
Sylvia,
ReplyDeleteI'm being treated at the BCCA in Vancouver. The trial I have joined is for front-line HL treatment. I assume your friend is refractory or relapsed so unfortunately she would not qualify for the trail. There is however an SGN-35 trial ongoing for relapsed/refractory which the Vancouver BCCA is participating in. I don't know whether or not it is currently recruiting but you can call them to find out: 604-977-6000
You should also contact Seattle Genetics about their compassionate use program, although she may have had to have participated in a trail previously to qualify.
Good luck,
Merch
Thanks for the info Merch. I wish you all the very best!
ReplyDeleteSylvia
My husband did this trial June 2010 was in remission for a year. This month he relapse :( . Over all this is a good drug it helps with much less side affects n it sounds promising. This drug is approved on California now so the doc is going to have him go through it again. Good luck to u best wishes n if u get a chance to b in this trial I think u should take it. Keep fighting n never give up!
ReplyDeleteHi -
ReplyDeleteI have ALCL did 6 rounds of CHOP but only achieved partial response. I'm exploring the SGN-35 hoping that will push me into CR. Just wondering what your experience has been on the SGN-35.
Thanks