ASCO launches first study with molecular targeted agents

Discussion Board Forums Clinical Trials ASCO launches first study with molecular targeted agents

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  • #90040
    marions
    Moderator
    #90039
    marions
    Moderator

    The TAPUR study centers have increased. To find a center near you use this link:
    http://www.tapur.org/participating-centers

    Those looking to be enrolled should discuss with their physicians participation in this clinical trial: https://clinicaltrials.gov/ct2/show/NCT02693535
    By scrolling down you are able to identify the 15 treatments arms with same tumor expression regardless of tumor type.
    Note: Genomic Testing Laboratories Optimized for TAPUR Reporting are:
    Caris Life Sciences ®
    Foundation Medicine, Inc

    This designation is provided to laboratories that meet the following criteria:

    CLIA certification
    College of American Pathologists (CAP) accreditation, and New York State (NYS) accreditation (for laboratories offering services to residents of New York)
    have a test that reports at least 75% of the TAPUR alterations*
    have developed a report that specifically identifies the TAPUR study genes and provides the optimized reports to participating TAPUR clinical centers
    *If this condition is not met, additional restrictions apply.

    #90021
    iowagirl
    Member

    Thanks for the new, additional info on the biopsy. Maria. I’ll keep that info in my folder for future reference. It’s good to know that the liquid biopsy was close to the same test results.

    Julie

    #90019
    mariajgb
    Member

    Julie,

    I believe the retail cost of the liquid biopsy was similar to what Foundation One was charging, I believe they said $5,000.

    My mom got her results back and it looks like her main mutations are ARID1A, IDH1, TP53, NF1 and CCNE amplification. Unfortunately it looks like she hasn’t developed any new mutations and that doesn’t leave us with many good options for new clinical trials since we already knew about the IDH1 mutation from her solid tumor biopsy. It does help me trust the accuracy of the new liquid tests, though, since the test found similar mutations to her previous solid tumor biopsy from Foundation One.

    #90035
    iowagirl
    Member

    Maria….thank you for posting this. I have heard of Guardant360 and liquid biopsies, but will be interested to see how this works. Please post more if your mom does the liquid biopsy. Also the financial info is very good info for us to have here. I just read info on Foundation One financial billing info and it sounds very similar. It was hard to find on the website, …under info for physicians , I think. I guess the idea was for the Dr. to pass along the billing info to the patient…but I can’t imagine many doctors taking the time to find out costs.

    Just curious, ….did they happen to mention what the “retail” cost billed to Medicare or Insurance was ? I think for a solid tumor sample through Foundation ONe the website now says something like $5800 plus or minus. I don’t have the exact amount right here to quote.

    Julie

    #90034
    mariajgb
    Member

    Not sure where else to post this, but it was helpful to me:

    When I contacted the TAPUR trial about enrolling my mother, they recommended that she get a liquid biopsy, since the tumor tissue from her last biopsy is over two years old, and she doesn’t have a good option for a new solid tumor biopsy. I’d been interested in liquid biopsies but was struggling to find a company that was currently doing it and they pointed me to Guardant360. Supposedly liquid biopsies have some advantages solid tumor biopsies don’t (simple blood draw, two weeks for results, don’t have to deal with heterogenous tumor tissue- should get full range of potential mutations). Guardant360 has a financial aid program and for Medicare patients they won’t bill the patient, even if Medicare won’t pay. We’re still waiting for the results from Guardant but wanted to pass the information along to anyone who might not have an easy biopsy location but wants mutation testing.

    #90020
    marions
    Moderator

    Looking to enroll?
    TAPUR study link to participating centers:
    http://www.tapur.org/participating-centers

    #90038
    marions
    Moderator
    #90037
    marions
    Moderator

    TAPUR study update: The University of Michigan achieved site activation in early June and is now enrolling participants.
    Patients interested in enrolling, please contact:
    Study Principal Investigator
    Ajjai Alva, MBBS
    U-M Comprehensive Cancer Center
    ajjai@med.umich.edu

    #90036
    marions
    Moderator

    Beatriz…..sorry for the late reply.
    1. advantages of getting into a clinical trial…..first line of treatment consists of Gemcitabine and a Platin drug, most likely Cisplatin. Some patients respond favorably, some do not. Those that benefit will stay on the drug combo until tumor progression. The question then becomes: what is the next systemic line of treatment? We don’t have a second line of treatment proven successful in large controlled studies and for a cancer such as this, a clinical trial may very well be beneficial.
    There are risk and benefits to consider:

    Possible Benefits
    You will have access to a new treatment that is not available to people outside the trial.
    The research team will watch you closely.
    If the treatment being studied is more effective than the standard treatment, you may be among the first to benefit.
    The trial may help scientists learn more about cancer and help people in the future.

    Possible Risk
    The new treatment may not be better than, or even as good as, the standard treatment.
    New treatments may have side effects that doctors do not expect or that are worse than those of the standard treatment.
    You may be required to make more visits to the doctor than if you were receiving standard treatment. You may have extra expenses related to these extra visits, such as travel and childcare costs.
    You may need extra tests. Some of the tests could be uncomfortable or time consuming.
    Even if a new treatment has benefits in some patients, it may not work for you.
    Health insurance may not cover all patient care costs in a trial.

    2. is molecular testing required for treatment with chemo/radiation. The answer is “no, it is not required.” Once diagnosed, physicians can administer chemo (cytotoxic treatments) or radiation based on what he/she believes is most beneficial to patient. Traditional cytotoxic chemotherapies usually kill rapidly dividing cells in the body by interfering with cell division.

    However; this is different for targeted agents (drugs) which identify faults in the DNA that drive cancer growth. Targeted cancer therapies are drugs designed to interfere with specific molecules necessary for tumor growth and progression, they don’t kill dividing cancer cells. This requires molecular testing results.

    Larger cancer institutes automatically conduct molecular testing however; they do not conduct testing for the entire genome as provided by larger labs such as Foundation One, Caris, Perthera, etc.

    DNA testing can be requested by the treating physician. Depending on the lab, patients may have to cover additional cost not covered by insurance.

    Hugs,
    Marion

    #90033
    marions
    Moderator

    As of June 6, forty-nine patients consented to participate in the TAPUR study and and as of now thirty-seven sites are participating twelve weeks post-launch.

    “TAPUR addresses a critical priority for achieving the promise of precision medicine: identifying existing, effective treatments for cancers based on their genomic profiles,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FASCO.

    This video explains more:
    https://www.youtube.com/watch?v=Y8cnmC8bLYI&feature=youtu.be

    #90032
    marions
    Moderator

    Since the opening of the TAPUR study on March 14, 2016, 49 patients have consented to participate and have either enrolled or are completing the screening process.

    Please note: Liquid Biopsy Test Results are accepted.

    Bayer and Merck are the most recent companies to sign on to provide study drugs at no cost to enrolled patients. I assume their drugs will address the PD-1 pathway, but will make sure to find out.

    TAPUR is currently underway at 37 clinical sites, and nearly 100 clinical sites around the country have expressed interest in participating in the study. New sites will be announced on this site as soon as information is released.

    United States, Michigan
    University of Michigan Not yet recruiting
    Ann Arbor, Michigan, United States, 48109
    Contact: Cancer AnswerLine Nurses 800-865-1125 canceranswerline@med.umich.edu

    liquid biopsy molecular analyses are accepted.

    Cancer Research Consortium of West Michigan Recruiting
    Grand Rapids, Michigan, United States, 49503
    Contact: Connie Szczepanek, RN 616-391-1230 crcwm-regulatory@crcwm.org
    Principal Investigator: Kathleen J. Yost, MD

    Michigan Cancer Research Consortium Recruiting
    Traverse City, Michigan, United States, 48341
    Contact: Beth LaVasseur, RN, MS 734-712-5658 Beth.LaVasseur@stjoeshealth.org
    Contact 877-590-5995
    Principal Investigator: Philip Stella, MD

    United States, North Carolina
    Carolina’s HealthCare System’s Levine Cancer Institute Recruiting
    Charlotte, North Carolina, United States, 28277
    Contact: Kelly Bumgarner, RN, CCRP 704-403-2520 Kelly.Bumgarner@carolinashealthcare.org
    Principal Investigator: Edward S. Kim, MD

    Note: European patients are able to enroll in a similar trial

    ASCO also will collaborate with the Netherlands Center for Personalized Cancer Treatment, which is conducting the Drug Rediscovery Protocol (DRUP) trial, a protocol similar to TAPUR that allows data sharing.
    EudraCT Number: 2015-004398-33
    Sponsor Protocol Number: M15DRU Start Date*: 2016-04-20
    Sponsor Name:Netherlands Cancer Institute

    Full Title: The Drug Rediscovery Protocol (DRUP trial) A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access

    Medical condition: Advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)

    #90031
    marions
    Moderator

    Additional updates:
    1. Study Launch:

    The trial officially opened on March 14, 2016, with 4 launch sites, for a total of 37 locations. Visit http://www.TAPUR.org for a list of participating sites and contact information.

    2. Information available on ClinicalTrials.gov (NCT 02693535)

    The TAPUR study is registered on ClinicalTrials.gov and can be found by searching for “TAPUR,” or by its NCT number (NCT02693535). The current list of study drugs is available, as well as detailed information on the study inclusion and exclusion criteria, and contact information for our participating sites (also available on http://www.TAPUR.org).

    3. Study Enrollment Update

    The TAPUR study enrolled its first participant on April 11, 2016, only a few short weeks after launching, and enrollment numbers continue to grow each week. Current participant enrollment numbers will be announced during ASCO’s Annual Meeting on June 4, 2016.

    #90030
    marions
    Moderator

    TAPUR Study provided brochures. Please click on link for full view:
    http://www.tapur.org/sites/tapur.org/files/TAPUR-Study-Patient-Brochure-May-2016.pdf

    #90029
    marions
    Moderator

    It is up to the discretion of physician to enroll patients treated with combination gemcitabine/cisplatin combination or single agent gemcitabine.

    I am one of several tumor board advocates for the TAPUR study and will report back or answer questions as they arise.

    Good luck to all.

    Hugs
    Marion

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