Saturday, August 16, 2008

Trabectedin Trials

There are 22 clinical trials of Trabectedin underway in the world right now, nine of which are “open” (meaning that they are still recruiting volunteers). I might be eligible for two of those studies:

1. “A Study of the Safety and Effectiveness of Trabectedin for the Treatment of Localized Myxoid / Round Liposarcoma”


2. “A Study to Provide Access to Trabectedin in Patients With Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment”


Study #1 is being conducted at treatment centers in Coeur D Alene, ID; Park Ridge, IL; Iowa City, IA; and Boston, MA. Study #2 is being conducted at 25 different centers including one in Los Angeles.

It might take some creative fact management but I believe that a case could be made for my meeting the inclusion criteria for these studies. And I learned during my first experience fifteen years ago that some doctors are willing to exaggerate some points and ignore others to get a patient into a clinical study if they want you to be there.

However, both studies specify exclusion criteria that includes “congestive heart failure . . . within one year before enrollment”. Now, I don’t know if I’ve been officially diagnosed with CHF. I believe that was the point of conducting the echocardiogram seventeen days ago, but when the, ahem, “large myxomatous mass” was imaged the proverbial shit hit the fan and I had to be on my A-game to get my butt out the door and into my car for the drive home rather than walking across the street to the hospital for emergency open heart surgery. So I don’t believe there is a report that states that I have CHF. And I think the point of the exclusion may be to avoid patients with CHF that is independent of the sarcoma. I don’t know. They may not know either. But I’ll inquire . . .

No comments: