What to Expect in Clinical Trial

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3/8/2014 10:54pm
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Replies: 7

Hi All. As Don was finishing up his 16 radiation treatments to his pelvic/groin area, he developed new pain and they found another tumor, so he had an additional 10 treatments to this new area. The goal of our awesome radiation oncologist was to get his pain diminished and get us to Florida for a break from this horrific, cold, snowy, icy winter.

We got to Florida and the weather has been gorgeous. Don is feeling ok. He developed a blood clot in his leg, but that was taken care of by medication (after 12 grueling hours in the ER and admission to a strange hospital!). 

Don is apparently having a "partial response" to Yervoy/Ipi (areas above the waist and in the brain have been stable since the end of August!). But below the waist, not so good.

Our next step will be to find a PD-1 or Anti-PD1 trial that seems most appropriate for him.

My question: what exactly is involved in taking part in a trial? I know there can be a lot of paperwork and tests and scans, etc. to qualify. But I'm wondering if the trial necessarily has to be local. Do all infusions have to be at the geographical location of the trial, or can they be given at another site?

Thanks for your help!

Janet

Janet,  As far as I know the trial site/location has to give the treatment, and that way it controls all the factors.  My husband also goes to Dana Farber (I think your husband still gets treated there too, right), but we spent almost a year traveling to Houston for treatment. My husband did the TILS trial in Houston, and even after that process was over, we flew back to Texas for two more scans  over the summer of 2012, because that was the trial protocol.  After that time period, the trial allowed scans in your own area and the results are sent to Houston.  It really depends on how things are specified in your trial paperwork, which will be reviewed with you and signed.  All our active treatment was done in Houston, during this trial.  Trials can't control other  remote locations, it's likely you will have to go there!!  All the best and enjoy the warm Florida weather!  Valerie (Phil's wife)

Hey Janet, 

Many of the answers to your questions will vary depending on the trial and its requirements. However, I can give you my experience. I went back and forth from my home in Chattanooga to Tampa, FL (Moffitt) for 21/2 years...every two weeks for the first 6 months and then every 3 months for 2 years, 3months. I am now going every 6 months for follow-up. My trial required an MRI of the brain and CT of neck, abdomen and chest every 3 months. I was allowed to get those at home one week prior to my Moffitt visits and express mail the results/cd's to Tampa so they would have them before the visit. All infusions and lab work had to be done at Moffitt. My trial also required several built in leukophoresis testing which required travel to Tampa 3 weeks in a row on at least one occasion. Costs with travel can be a big factor as none of my travel expenses were paid by anyone but me! However, there are agencies that can help with that and many hospitals have a place you can stay...Hope House, etc. And, yes, there are lots of scans and paperwork issues that have to be completed before starting any trial. They vary by trial requirements, but are usually pretty doable. The hardest part is getting them all done with way the trial wants them and within the time limits (like within say 28 days of trial start) without something you've already completed running outside the timeframe.

Hang in there! I wish you my best! The entire story of my trial adventure is on my blog if interested.          Yours, celeste

chaoticallypreciselifeloveandmelanoma.blogspot.com

Thank you both for your responses. I had assumed that the trials had to control the drug administration and followups, but figured it was better to ask than to "assume." Celeste, I can't imagine the cost of traveling like that! but, Tampa's only a few hours from us when we're here in Florida!

Janet

Thank you both for your responses. I had assumed that the trials had to control the drug administration and followups, but figured it was better to ask than to "assume." Celeste, I can't imagine the cost of traveling like that! but, Tampa's only a few hours from us when we're here in Florida!

Janet

It's been kind-of crazy for sure!!!  Since you are near...you should definitely check with Moffitt about any trials that are potentially beneficial for Don.  I know an anti-PD1 post ipi arm was added to my trial, though I am not certain slots remain in that particular arm.  The investigators and clinical trial coordinators are good peeps and work hard to find help for those who need it!  Hang in there and keep us posted on what you decide.  Yours, Celeste

chaoticallypreciselifeloveandmelanoma.blogspot.com

Janet:

A lot of people have questions about clinical trials, but in melanoma this is often the best way to have access to the most cutting edge treatments.  Trials offer the best supportive care for patients, including more tests and scans to see exactly what is going on.  The disadvantage is around travel, as you have noted. Being in a trail means repeated trips to the center where the trial is taking place, and for some people that is a real challenge.

Some of the standard care can be done locally, but drug administration and scans are almost always done at the host institution. This is a bit different if you are talking about an oral drug, but PD-1 doesn't fall into that category.

The MRF is hosting a Twitter Chat with TJ Sharp, who goes by the handle "Patient 1". He was the first person accrued into a trial and is currently in a different trial. He will talk about, and answer questions about what is like to be involved in a trial. The Chat is this Thursday at 1:00 eastern. You can find more information here:  

http://www.melanoma.org/get-involved/calendar-of-events/twitter-chat-cli...

Tim--MRF

 

Thanks, Tim! Still fighting the fight!

Janet