Inhaled doxorubicin trial

Overview

I participated in a phase I trial for a new technique to receive doxorubicin, a chemo drug which has been successful with Ewing's sarcoma. Since this is my first trial, I am learning both about the trial process and the drug and its effects.

I was able to receive only 2 cycles of the medication.

Notes from doctor's visit on 1/13/03 and 1/20/03

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The purpose of the trial is to determine dosing. It, of course, would be nice if it helped me. There have been 2 responses in the 25 patients who have received it; one of those was a sarcoma, and the other was a lung cancer. Another 3 patients were stable while on the trial; 2 of these were sarcoma and one thyroid.

bulletSince my current mets are in my lungs only, I am a good candiate for the trial. (Unlike conventional chemotherapy, which is most often administered by IV or pill and is therefore systemic in nature, this clinical trail involves the inhalation of the drug and is thought to be more "localized in nature".)
bulletI can receive up to 6 cycles. I'll have a chest CT after each set of 2 cycles to see if my nodules are stable or decreasing in size. If they aren't, then I'll move onto another clinical trial.
bulletThe cycle is 3 weeks. I see her on a Monday for a check-up. Before I get the drug, I'll have a chest x-ray, a pulmonary function test (PFT), and blood work. I get the drug on the following Tuesday. I will receive the drug thru a mouth piece. While receiving the drug, I will be in a tent with a gown on and special goggles. The tent is to keep others from breathing in the drug and the goggles are to keep it from my eyes. The gown is to keep it off my skin (and my clothes). I will talk with her once a week for the next two weeks.
bulletThe first cycle will take all day; after I receive the drug, they will take blood a number of times to verify that the drug isn't in my blood stream. The second cycle, they will test blood for 2 hours after. The remaining cycles, I need only stay for 30 minutes after I get the drug.
bulletThe main side effect that they are worried about is fibrosis in the lungs (i.e., scarring). The scarring decreases the lungs ability to get oxygen from air, so it increases shortness of breath. So far, in the 25 patients that have been on the trial, 2 have had fibrosis. They don't know if the fibrosis was caused by the drug, but are assuming it was. One case was temporary (his output from the PFT decreased and then improved once the drug was stopped). In the other case, the patient needed to go on a ventilator. If my PFT results decrease by 17% or more, this will lead them to think that I might be developing fibrosis. So, they will stop my participation in the trial.
bulletI will need a number of base-line tests before the first cycle: chest CT scan, EKG, Echo, PFT, chest x-ray, blood work. I will need a test where I breathe in radioactive particles to determine my dosing.

 

Schedule

The appointments which I currently have:

bulletJan 16 - base-line tests
bulletJan 20 - meet with White; sign consent form
bulletJan 23 - dosing study
bulletJan 28 - 1st chemo
bulletFeb 17 - meet with White; tests (blood, chest x-ray, PFT)
bulletFeb 18 - 2nd chemo
bulletMarch 10 - meet with White; tests (blood, CT chest scan, PFT)

 

Pointers

ClinicalTrials.gov listing of the Inhalable Adriamycin trial

bullet abstract presenting preliminary results of the trial
bullet information about the trial with lung cancer

Copyright 2003 The Shriver Family: Last modified: 01/06/04.