Help w/ This Trial Please

[zephyr66]

Hi Catherine… Below is a link to a trial I was alerted to. First of all, does this sound like a good trial to you? It’s PDL-1 and I don’t know the difference between PD1 and PDL-1. We are most interested in the one in Orange, CA but would also drive to Los Angeles, CA. I called the contact person Roxanne for the trial listed but her mailbox was full. I called their main number and pressed 0 for an operator and it rang and rang and then disconnected me. Do you know any other shortcuts to talk to someone about a trial?

http://clinicaltrials.gov/ct2/show/NCT01693562?term=medi4736&cond=%22Melanoma%22&rank=1” class=”bbcode_url”>http://clinicaltrials.gov/ct2/show/NCT01693562?term=medi4736&cond=%22Melanoma%22&rank=1

We just found out Amy had advanced on the BRAF/MEK combo – last CT a couple weeks ago shows tumor in spine growing again and multiple subcentimeter nodules in both lobes of the liver. She doesn’t know yet and I haven’t told her because she has family visiting for a week and I want her to enjoy the visit. They leave the morning we go up to Los Angeles. We go for our final exit visit in Los Angeles for the BRAF/MEK trial and docs will be reviewing her scans there.

There are two other trials at UCLA but I’ve never heard of them… I posted a post several days ago and nobody responded so I’m assuming nobody else knows what they are either which doesn’t make them sound encouraging. I feel like a PD1 trial is our last hope and this is the only thing I’ve found and it’s so frustrating not to be able to contact anyone there.

Hoping you have a lead.

[jamesa]

Hi,

I am so sorry to hear about Amy. I did a little “goggling” for you, and I think that I found the clinical trial that you are looking for:

It appears that the trial is at UCI at the Chao Cancer Center in Orange CA:

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

Protocol Number: UCI-13-35

Condition/Disease: Cancer – Colon, Cancer – Kidney, Cancer – Lung, Cancer – Melanoma, skin

Principal Investigator: Sai-Hong Ignatius Ou

Status: Open

Treatment: Therapeutic

Drugs: MEDI4736

Phase: I

Age Group: Adult

Scope: Local

Learn More:

For information about cancer clinical trials at the UC Irvine Health Chao Family Comprehensive Cancer Center, call toll-free 877-UC-STUDY (877-827-8839) or email ucstudy@uci.edu

Good Luck and please keep us posted.

James

[Catherine Poole]

I would say the PDL is as promising as PD1. This trial was closed at Sloan and I’m not sure about other locations without calling each one. I will see if I can find out more for you.

[zephyr66]

james,

thank you for the info. i did call and got right to someone. not sure if she will qualify because of creatinine levels, but it’s still a maybe.

do you know the difference between pd1 and pdl1 for melanoma? this trial is unique in that it’s open to different types of cancers.

[Catherine Poole]

Actually this isn’t that unique in being for other cancers, PD1 is very useful for lung cancer and the BRAFs are being used in a variety of cancer diseases. Here is an explanation from ASCO on PD1 and PDL: The anti-PD-1 and anti-PD-L1 antibodies potentiate immune responses by blocking the interaction between the PD-1 protein, a T-cell co-inhibitory receptor, and one of its ligands, PD-L1—critical players in the ability of tumor cells to evade the host’s immune system. The anti-PD-L1 antibody MPDL3280A yielded impressive single-agent activity against a variety of solid tumors

[Catherine Poole]

Sad to say as I thought, this trial for melanoma is closed and fully accrued. The other PDL is combined with the braf/mek. I didn’t see your other post about trials you were looking at. Can you repost it? I didn’t find it in a search either.

[zephyr66]

Catherine,

I just got off the phone with UC Irvine. So, are you saying this trial I posted above is closed for PDL1 and only open for PDL1 and BRAF? Should I call and confirm? I didn’t ask but just made an appt. for the trial number. It’s very expensive for the first visit so if it’s for BRAF combo, I don’t think it would be good to go. She advanced on BRAF and I don’t think her kidneys could handle both meds together.

Sylvia

[Catherine Poole]

She would not be allowed in the PDL combined with braf/mek. I was told by the company that makes the PDL that they were fully accrued for the PDL alone, but maybe they have any opening there. I would make double sure which trial it is and whether the openings if they exist are for melanoma.

[zephyr66]

catherine,

ugh. we have the appt. scheduled and i called back and got a grumpy receptionist who seemed to care less and said she would pass my questions on to the nurse to the doc who we’re seeing and that she will get back to me “when she can”. considering they charge almost $800 just to have a visit to see if you fully qualify, i need to have these questions answered beforehand. plus, i lose a day’s work and that’s more money right there.

the other two trials i posted are on the stage 4 board. it’s the 8th post down and is titled “Info on Suggested Trials Please”. yes, if you could take a look at these and tell me any of your thoughts if you know anything about them.

thank you so much.

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