Cediranib trial for adults at NCI

[Beth]

I am happy to share the news that NCI is up and running with a trial for adults. I just spoke to the Research Nurse, Mary Ann Yancey, who asked me to share the news. I don't know any of the details, other than it is a Phase II trial. Contact Mary Ann at 301 435-9227 for more information.

[Olga]

Beth, thank you so much, I've checked the registry for the trials and this trial is here:

Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma
http://clinicaltrials.gov/ct2/show/NCT00942877
Eligibility:

Patients must have histologically or cytologically confirmed metastatic alveolar soft

part sarcoma.

Age greater than or equal to 18 years old.

Adequate organ function.

Design:

Patients will be treated with AZD2171 at 30 mg by mouth once a day for 28 days

(28-day cycles).

Blood pressure will be monitored weekly for the first 2 cycles then every 2 weeks for

the remainder of the study (unless patients have experienced elevated blood pressure

requiring drug therapy).

CT scans will be performed at baseline and every 2 cycles for restaging.

[Amanda]

Hello Beth,
I just left a message for the nurse about more information for the trial.
I am not sure if they will take me but it i worth a shot.

Thank you very much for posting this!

In healing hopes for all!

Amanda R

[Amanda]

Hello,
I just wanted to let everyone know they are still looking for paitents and i receved a fast call back from the nurse and she was very nice!
I may not be elligable right now because this seems for the moment stable.They are looking into this and will be calling me back and also sending me via mail the information and also the paper work.

Amanda R

[Amanda]

Hello,
I called the trial and found out a new RN is taking the calls now for the trial and the new phone number is 301-435-2715.

In healing hopes for all!

Amanda

[Arch]

Hi All,

This trial at NCI is not taking any more patients at the moment, furthur enrollment depends on the findings of patients that are presently on the trial.
I hope this is just a 4-6 weeks break and enrollment would start in the new year.

Arch

[Bonni Hess]

Dear Arch,
Thank you for posting this important update about the current (Hopefully only temporary) suspension of patient enrollment for the NIH ASPS Cediranib Clinical Trial. This is very disappointing for everyone who were Hoping to enroll in the Trial sometime soon, and it is very perplexing as to why enrollment has been suspended, but I know that interim results have been required in previous Cediranib Trials. I share your Hope Arch that the evaluation of the treatment results of the patients currently enrolled in the Trial will show successful responses to the medication which will then allow continuation of the Trial as soon as possible.
With special caring thoughts and continued Hope,
Bonni

[wendik]

HI everyone, this is my first post, but just wanted to let you know that NCI is once again actively recruiting for Phase II trials to begin sometime in January. My son Matt has been accepted and we are just waiting for a start date. The contact we have been communicating with is Janelle Bingham, R.N.
Hope this info helps you.

Love and best wishes to all,

Wendy

[Olga]

Wendy, welcome to the board and thank you for the good news. It means that first stage of this Phase 2 trial has met its goals and there is enough information to consider the trial worthwhile and proceed with the enrollment!

[Bonni Hess]

Dear Wendy,
Thank you for joining our Board and for sharing this very important and significantly encouraging information. As Olga, said, the re-opening of the Trial for enrollment and its continuation indicates that the interim evaluation of the Trial objectives thus far has shown positive results. My special thoughts and best wishes are with your son for a very successful response to the Cediranib medication. If you have any questions regarding our daughter Brittany's now eight month Cediranib treatment experience, please feel free to contact me on this Board, or at my personal e-mail address which is BonniHess@aol.com. Also, if possible when your time and the situation allow, please update the Board on information regarding Matt's date of ASPS diagnosis, treatment history, disease status, and his Cediranib Clinical Trial experience and results. As you may have observed from the postings on this Board, information sharing and communication with each other is a vitally important weapon in fighting this very challenging disease. Take care Wendy, know that I will be holding Matt and your family very close in my heart, thoughts, and prayers, and keep in touch as you are able.
With special caring, healing wishes, and continued Hope,
Bonni Hess, mother of 27 year old Brittany diagnosed at age 19 in July 2001

[Arch]

Dear All,

As per the clinicaltrials.gov website, the estimated enrollment for the cediranib trial has been revised to 60(I think it was 27 initially).
So more spots are available for other ASPS patients.

Arch

[Arch]

Another Cediranib trial is starting in UK exclusively for ASPS patients. Details are here -
http://clinicaltrials.gov/ct2/show/NCT0 ... oma&rank=3

[Ivan]

Another Cediranib trial is starting in UK exclusively for ASPS patients. Details are here -
http://clinicaltrials.gov/ct2/show/NCT0 ... oma&rank=3

That's a double blind placebo controlled trial, so that means that half the patients will NOT be receiving medication.

I am not sure there are too many people who would want to only get cediranib with a 50% chance

[Olga]

If the enrollment criteria are precisely observed, only patients with the progressive disease and no other treatment options have to be accepted (when even no surgery or ablation options are available and other suitable systemic treatment are already tried - sunitinib, vinca alcaloids, gemcitabine, phase 2 clinical trials with no placebo) - then when there are no other options at all left - people will take even phase 3 trial with the placebo option. Clinical trial is NOT the treatment until it is proven to be the one by the phase 3 clinical trial with the increase in OS (overall survival) demonstrated. Until then we can only see the signs of the activity and the increases in the PFS (progression free survival) when the OS in reality might decrease. We should not loose the clear mind as even if we want to believe that it might be the treatment, it might be only a temporary brakes applied with the acceleration after - in that case the very people that got a placebo might win.

[argonaut]

Is this trial still accepting patients?