Clinical Trial Information

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lilacbreastedroller
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Clinical Trial Information

Postby lilacbreastedroller » Mon Mar 02, 2015 11:21 am

In this thread, I’d like to post some information about clinical trials in the US, based on my experience participating (as a lab rat) in two of them! Feel free to add to this.

1. Where to find trials

http://www.clinicaltrials.gov is the official US Government sponsored database for clinical trials. the main portal of this site offers a number of online tutorials to help users locate suitable trials. Other intermediaries offer trial finders as well (others, feel free to post these - I have not used them.)

2. Where are trials conducted

Trials can be conducted by oncologists everywhere, not just in major cities, universities, or in large hospitals. The “mothership” for US trials is the National Cancer Institute (NCI) which is part of the National Institutes of Health (NIH), a branch of the US Department of Health and Human Services (HHS.) NCI runs trials at headquarters in Maryland and at regional centers across the US. Here is a link to help find just the trials run by NCI:
http://www.cancer.gov/clinicaltrials

3. Cost

Trials at NCI facilities are completely free - all drugs, scans, doctors visits, surgery, hospitalization, etc, and even travel and lodging are reimbursable.

Trials at other locations are usually cost shared between the patient (including the insurance provider) and the test facility. Trial drugs/treatments are always free of charge. Certain tests, scans and medical consultations are free, and others are the responsibility of the patient. Best to sort this out in advance. Some insurance policies do not cover costs associated with clinical trials. In some US states, insurance companies are not required to pay portions of clinical trial expenses, so they don’t… best to read your policy for specific coverage first, or contact the company directly to be sure.


4. When to seek out clinical trials

Generally speaking, clinical trials aren’t the first option when diagnosed with cancer. For ethical reasons, doctors usually don’t administer experimental drugs (and other treatments) to patients who have not exhausted other options, on the chance that a proven, approved drug/treatment might be life-saving. But, that being said, it may be possible to participate in some studies as a newbie - it’s best to carefully read the “inclusion” and “exclusion” criteria listed - each trial provides points of contacts, and you can always ask..

Time is big factor. It’s best to try trials when you’re not too close to “the end.” Depending on the institution, it can be a month or more before you can be admitted to the trial and receive any treatment, due to administrative requirements (registration, scans, screening, meetings with research doctors, etc.) Many require patients to be off of previous chemo for at least 4-6 weeks prior to starting the experimental treatment, in order to “clean” it out of their systems. And some require tests that you may not have had already, like MSI. That also adds time.

5. How to determine if you qualify for a particular trial

Trial announcements on http://www.clinicaltrials.gov follow the same standard format, and two sections contain general and specific qualification details: “purpose” and “eligibility.” The purpose is at the very beginning of the announcement and discusses which types and stages of cancers are being studied. Further into the announcement is the eligibility section, which in addition to age and gender requirements, contains the “inclusion” and “exclusion” criteria which specify conditions which need to be present, or absent, in order to qualify for the trial. Some are easy to understand, others you might want to run past your oncologist because they are very technical in nature. If you have any questions as to whether you would qualify or not, each trial provides at least two points of contact, so just ask them.

**Many studies state that participants may not have had chemotherapy or biologic agents within xx weeks before the first dose of study treatment. Don’t worry about this. It doesn’t mean this time must elapse before you are accepted into the trial. It just means that you’d have to stop your current treatment and wait a certain amount of time before actually receiving the experimental treatment.

6. Suggestions for how to choose a trial

Make a list of all the trials you're interested in. Eliminate any for which you do not meet the criteria. Then consider:

  • side-effects (are they permanent?) or risks?
  • how long will the protocol take?
  • where you need to go (distance) to receive the treatment(s)
  • costs both in $ and time away from family/work
  • reputation of the organization backing the trial
  • whether it's potentially curative or not
  • how likely is the hoped-for outcome
  • are you healthy enough NOW to withstand the protocol
  • have you got anything to lose? anything to gain?
  • will participating in this trial preclude you from a future treatment you might want to try if this one doesn't work?

7. Phases Explained

Clinical trials to test new cancer treatments involve a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. They also make sure that the treatment has some benefit, such as slowing tumor growth. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.

There are also very early (phase 0) and later (phase 4) phase clinical trials. These trials are less common. Phase 0 trials are very small trials that help researchers decide if a new agent should be tested in a phase 1 trial and submitted for FDA approval. Phase 4 trials look at long-term safety and effectiveness and take place after a new treatment has been FDA approved and is on the market.

Each trial will state up-front which phase it is, usually in the “purpose” section. 


    Phase 1 - Is the treatment safe?
    The goal is to find out if the treatment has some effect, how it is metabolized, what the most frequent and serious side effects are, how the new treatment should be given (by mouth, in a vein), and to determine a safe dose.

    Phase 2 - Does the treatment work?
    Drugs/treatments (and safety) are studied further in a larger pool of participants to determine effectiveness. Specific cancers are often targeted.

    Phase 3 - Is the new treatment better?
    If a treatment does show results in earlier phases, in this phase it is compared with the current standard treatment(s) to demonstrate if it is better or, perhaps is equivalent but with fewer adverse side effects.

8. Randomization, Placebos Explained

Placebos: Placebos are NOT ALWAYS GIVEN!!!! This is a common misunderstanding. Each trial will state clearly if placebos (sugar pill) are given, usually up front. If a trial does not mention placebo anywhere in the description, placebos are not given. Period!

Some trials compare a new drug to a placebo. If your cancer is fairly stable and you have a few years to live, it might be worth the risk to try this, if you can afford to potentially go without treatment for 3-6 months if you are given the placebo.

Some trials test cocktails, so you’d receive an approved drug (like Stivarga/Regorafenib) plus either a new drug or a placebo. On the positive side, if due to your insurance situation your out-of-pocket chemo costs are astronomical, this option enables you to obtain standard treatment for free, and potentially a new drug.

Randomization: Each trial will state up-front whether it is randomized or not. Phase 3 trials are nearly all randomized, and Phase 2s can be but usually are not. Randomization and placebo are not the same thing - Most of the time phase 3 trials compare standard drugs against new drugs, randomized, with NO placebo at all.

When new drugs are compared to standard treatment, like erbitux and 5-FU , or a placebo, selection is randomized in order to avoid bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatment being tested. For example, if doctors could choose which patients to assign to which groups, some might assign healthier patients to the treatment group and sicker patients to the control group, without meaning to. This might affect trial results. Randomization helps ensure that this does not happen.

In the simplest trial design, one group receives the new treatment. This is the investigational group. The other group receives standard therapy. This is the control group. At several points during and at the end of the clinical trial, researchers compare the groups to see which treatment is more effective or has fewer side effects. A computer is usually used to assign patients to groups.

• Single-blinded trials are those in which you do not know which group you are in and which intervention you are receiving until the trial is over.
• Double-blinded trials are those in which neither you nor the investigators know which group you are in until the end of the trial.

If you are really seeking a new drug, it is risky to choose a randomized study, and you may not qualify anyway if you’ve already had the standard treatment it is being compared to (if a phase 3 study). If this is the case, keep searching the database: frequently there can be more than one study for the same drug, each slightly different, or, several drug companies might be developing similar products, such as the PD-1 inhibitors, and some of the other drugs’ studies may not be randomized.

9. How to apply, and what is it is like to be in a trial?

Applying is simply contacting the trial points of contact, and submitting information they ask for. Typically they’ll want discs of your most recent scans, bloodwork, and doctor’s notes. Some of the info you’ll provide, and some your oncologist/doctor will need to submit. Definitely read through the inclusion and exclusion criteria first, and don’t waste your time on trials which you clearly do not qualify for; there is not room for much negotiation as the studies have specific parameters. Don’t make assumptions as to your disqualification either; if something isn’t listed as exclusion criteria, chances are it isn’t one for that particular trial. When in doubt, talk to your oncologist or contact the trial directly.

Each trial is led by a Principal Investigator (PI) who is usually a medical doctor or PhD. Often, he or she is listed as a point of contact in the trial, along with an assistant. Depending on the institution and the scale of the trial, the PI may have several levels of assistants and associates whom you may deal with during participation. You may interact with the PI at every appointment, or very rarely, depending on the study.

You will be required to read and agree to an informed consent statement, which will explain to you the risks and potential hazards of receiving the trial treatments, and your rights as a patient, including the right to withdraw at any time. The informed consent may also cover the institution’s rights to use your body products (blood, tissue samples, etc) during and after the study, as well as if you want to be contacted after the study has been completed.

Participating in a trial is not much different than seeing an oncologist and having a regular chemo appointment, however the length of time you can participate in the study and receive treatment often is determined by your progress against pre-set benchmarks. Each study is different. My NCI experience has been over the top because groups of people in white lab coats would randomly come in and chat with me, but otherwise, it’s been business as usual for both trials I’ve been in. Both trial experiences were very positive for me, even though I was booted out of the first trial for lack of results; the care I received was outstanding, and the research doctors and nurses were very professional.
Last edited by lilacbreastedroller on Mon Apr 13, 2015 2:46 pm, edited 2 times in total.
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

sjring
Posts: 181
Joined: Mon Jun 30, 2014 3:16 pm
Location: Philadelphia, PA

Re: Clinical Trial Information

Postby sjring » Mon Mar 02, 2015 2:47 pm

lilacbreastedroller,

That's actually a very good primer on the clinical trial process.

There's some nomenclature and one additional point I want to add. The doctor running a trial is ofter referred to as the Investigator often the Principal Investigator however at larger sites the Principal Investigator will be the top doc at the site conducting the trial there and he or she may have several Sub Investigators under them having more general contact with the patient. Te hospital or clinic where the trial is being held, refered to as an Investigational Site.

If you are interested in participating in a trial, the Investigator must present you with an Informed Consent Form (or ICF). This discusses, in plain english (or translated into approved languages), what the trial is, how it is conducted, what the possible risks to you are and what financial obligations or payments you will have or receive (Some studies will pay a stipend to participants, but these tend to be Sponsor (pharmaceutical company) initiated studies and not usually studies conducted by educational institutions). It is very important that you read and understand this document before you agree to participate. You will be required to sign the document if you do decide to participate.

Also in adition to randomized trials there are also Open Label trials, where the investigational drug is known to all involved and all patients are receiving this drug. Some trials are structured as a randomized trial initially, and then if the drug is shown to be safe and effective, the patients may be offered the opportunity to roll into the open label study. Whether this option is available should be disclosed in the ICF.
50 YO Husband & father of 2 teenagers.
DX 9/9/13 Stage 4 cc (at age 48)
16 Rounds FOLFOX + Avastin (Oct-13 to May-14)
Maintenance chemo - Avastin & 5-FU infusions (Jun-14 to Jul-15)
Jul-15: Mets to lymph nodes, resuming FOLFOX
Sep-15: MRI showed stability, back to maintenance chemo.

Ceebo
Posts: 132
Joined: Sat Feb 14, 2015 9:15 am
Location: Southwest Michigan

Re: Clinical Trial Information

Postby Ceebo » Mon Mar 02, 2015 4:08 pm

Thanks to both of you for some excellent information. It is very helpful.
DH 64 Stage 4 on 4/14 ; cecal tumor; 5+ nodes ; mets to liver; colon resection
5/14 FOLFOX
9/14 - Liver surgery aborted; peri mets
10/14 CT mult.1-2 mm lung mets; FOLFIRI & Avastin
1/15 CT -liver & lung mets shrinking
3/15 PET - ? New met. site colon; CEA rising
7/15 Chemo has failed; looking for clinical trial
9/29/15 started TAS-102 trial
KRAS mutant; MSS

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lilacbreastedroller
Posts: 90
Joined: Thu Sep 05, 2013 10:25 am

Re: Clinical Trial Information

Postby lilacbreastedroller » Wed Mar 04, 2015 1:00 pm

You're welcome! Did anyone watch the latest installment of HBO’s “Vice” series, “Special Report: Killing Cancerhttp://killingcancer.vice.com Very interesting program. They profiled several clinical trials for different cancers where genetically modified viruses such as measles and HIV were used to zap tumors. Several participants’ cancers were completely eradicated. Gone. As in gone.

Here is a link a colorectal trial in Ohio (thru Ohio State University) using a modified measles virus - it is a phase 1 trial

https://www.clinicaltrials.gov/ct2/show/NCT01376505?term=measles+cancer&recr=Open&rank=7

cheers
Karin
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

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vilca11
Posts: 730
Joined: Fri Feb 14, 2014 11:19 am
Location: Moscow, Russia; Baltimore, USA 1992; Vilcabamba, Ecuador 2012

Re: Clinical Trial Information

Postby vilca11 » Wed Mar 04, 2015 3:14 pm

Good job, Karin and sjring, I wonder how to keep this subject on the top, like other important educational info for all (e.g., abbreviations, etc). Admin people can do it - anyone?
Thanks, Vilca
11/2005 CC stage 1, F,50yo@dx
Mod dif adenocar, MSS, APC, TP53, CEAs1.6-4.8
1/12 1met liver@Vena Cava, RFA, 3oxi,11 5FU
8/13 2 mets same place,SBRT
4/14 2 Xeliri+Avastin
5/14 Nano Knife liver same 2 mets
6/14 2 Xeliri, ADAPT
4/15 PET, 2 same mets,Cryo Liver
5/15 MJ Oil, Herbs, Suppl, ADAPT
10/15 PET, same area, doubled in size, high SUV
10/15 RH, HAI, visceral involv., no LN
2/16 red FF, 50% red dose FUDR, CEA trends up
3/16 CT, PET, MRI L.Lobe all in small tumors
4/16 No acceptable options, going home

sjring
Posts: 181
Joined: Mon Jun 30, 2014 3:16 pm
Location: Philadelphia, PA

Re: Clinical Trial Information

Postby sjring » Thu Mar 05, 2015 10:43 am

vilca11 wrote:Good job, Karin and sjring, I wonder how to keep this subject on the top, like other important educational info for all (e.g., abbreviations, etc). Admin people can do it - anyone?
Thanks, Vilca


I think that would be up to one of the moderators.
50 YO Husband & father of 2 teenagers.
DX 9/9/13 Stage 4 cc (at age 48)
16 Rounds FOLFOX + Avastin (Oct-13 to May-14)
Maintenance chemo - Avastin & 5-FU infusions (Jun-14 to Jul-15)
Jul-15: Mets to lymph nodes, resuming FOLFOX
Sep-15: MRI showed stability, back to maintenance chemo.

sjring
Posts: 181
Joined: Mon Jun 30, 2014 3:16 pm
Location: Philadelphia, PA

Re: Clinical Trial Information

Postby sjring » Thu Mar 05, 2015 10:50 am

lilacbreastedroller wrote:You're welcome! Did anyone watch the latest installment of HBO’s “Vice” series, “Special Report: Killing Cancerhttp://killingcancer.vice.com Very interesting program. They profiled several clinical trials for different cancers where genetically modified viruses such as measles and HIV were used to zap tumors. Several participants’ cancers were completely eradicated. Gone. As in gone.

Here is a link a colorectal trial in Ohio (thru Ohio State University) using a modified measles virus - it is a phase 1 trial

https://www.clinicaltrials.gov/ct2/show/NCT01376505?term=measles+cancer&recr=Open&rank=7

cheers
Karin


I did, it was a fascinating program, as was the Frontline program that was on a couple weeks ago about end of life discussions that doctors have with patients.

I really think that between what was on Vice, the immunotherapy trials going on, and the recent work by Univ. of PA researchers that identified a protein in cells that cancer cells seem to need to survive, we are on the cusp of some major improvement in treatment (and cusp in clinical research term probably means 10 years or so but still).

I'm also becoming very interested in the link between CRC and low Vitamin D levels. I think there are clinical research opportunities in this area especially among gastric bypass patients (sorry, personal bias which is why I'm not a researcher, just a finance guy in the research industry).
50 YO Husband & father of 2 teenagers.
DX 9/9/13 Stage 4 cc (at age 48)
16 Rounds FOLFOX + Avastin (Oct-13 to May-14)
Maintenance chemo - Avastin & 5-FU infusions (Jun-14 to Jul-15)
Jul-15: Mets to lymph nodes, resuming FOLFOX
Sep-15: MRI showed stability, back to maintenance chemo.

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CRguy
Posts: 10473
Joined: Sun Feb 10, 2008 6:00 pm

Re: Clinical Trial Information

Postby CRguy » Thu Mar 05, 2015 10:53 am

We are in discussions about some forum updates and changes,
but for now use the SEARCH this Forum function at the top of the first page
to check for any topic which you need more information about.

To keep the topic on the first page just keep it active or BUMP it up !
Cheers
CRguy
Caregiver x 4
Stage IV A rectal cancer/lung met
17 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far

User avatar
lilacbreastedroller
Posts: 90
Joined: Thu Sep 05, 2013 10:25 am

Re: Clinical Trial Information

Postby lilacbreastedroller » Thu Mar 05, 2015 4:17 pm

Thanks CRguy - A permanent thread about clinical trials would be really useful, with basic information and maybe updated links to CRC trials. Before I started doing trials I knew very little about them. I didn't know NCI was free and I did think that trials all were randomized. For now, until such a thread is established, I'll keep posting to this one to keep it relevant.

Sjring: I didn't see the Frontline special. It sounds interesting, though. Like you I'm fascinated with the new developments. Existing treatment (chemo, radiation, surgery) works for most people who are diagnosed early, but for us widespread metastatic types starting from solid tumors, right now there isn't a lot of hope for us using conventional methods. Immunotherapy shows early promise for us basket cases. I loved the Vice video of the exploding tumors during one of the virus trials. That was a graphic I could relate to!

For me, one of the most difficult things about searching for trials is deciphering the titles. Some are obvious, others not so much. It would be really good if right after an article or a TV program about a cancer success story in clinical trials came out, links to the trials could be posted here if any involved CRC...
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

User avatar
lilacbreastedroller
Posts: 90
Joined: Thu Sep 05, 2013 10:25 am

Re: Clinical Trial Information

Postby lilacbreastedroller » Mon Apr 13, 2015 2:46 pm

** I just edited my initial post to incorporate people's suggestions. Thanks, everybody.

- Karin
dx 6/1/12@45yo
RT, 4 liv, 5 lung
7/12 FOLFOX
2/13 Xeloda 4k mg/d
7/13 DC VAX,1k mg/d metro Xel
11/13 Erbi, Irino
6/14 clinical trial lirilumab, nivolumab
9/14 Stivarga
1/15 clinical trial immunotherapy (young TILs)
RT, mets to liv, lung, adrenal, lns

dudette
Posts: 106
Joined: Sat Oct 17, 2015 10:04 am

Re: Clinical Trial Information

Postby dudette » Sat Nov 05, 2016 6:38 am

*bump*
Temi
Dx 03/2015 @ age 41 - CC stage IV - pT3 N2b (14/29) cM1 (hep) L1 V1 Pn1 R1
Wild K-RAS, N-RAS, BRAF / MSS
unresectable mets liver 60% + lungs
Surgery
04/15 - sigmoid resect.
07/16 - hysterectomy (ovaries)
Chemo
05-06/15 - 4 x Folfirinox
12/15 - 02/16 4 x Xeliri + Avastin
03-05/16 9 x Xeloda
09-12/16 Folfiri + Cetuximab
01/2017 - metronomic chemo + methadone
July 20, 2107 - Temi has passed away.

User avatar
CRguy
Posts: 10473
Joined: Sun Feb 10, 2008 6:00 pm

Re: Clinical Trial Information

Postby CRguy » Sat Nov 05, 2016 1:03 pm

We have now linked THIS topic by lilacbreastedroller in the first post of the sticky CLINICAL TRIALS and Important Links

Cheers All
CRguy
Caregiver x 4
Stage IV A rectal cancer/lung met
17 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far


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