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Thread: PanCan Clinical Trials

  1. #21
    Newbie Top User BobInBonita's Avatar
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    Originally posted by LancePeace

    [url]http://clinicaltrials.gov/ct2/show/NCT01453153[/url]
    The Trial above. Article below.

    Overall survival increases in mice

    Art Chimes Voice of America March 20 2012

    Scientists at Fred Hutchinson Cancer Research Center report they've found a way to break through the unique biological barrier a pancreas cancer tumor builds around itself in mice.
    Scientists in Seattle are reporting a potential breakthrough in the treatment of pancreas cancer, a disease which stubbornly resists most therapies.

    Pancreas cancer tumors are resistent to chemotherapy partly because they form a biological barrier around themselves.

    Researchers at the Fred Hutchinson Cancer Research Center believe they've found a way to break that barrier down.

    "Pancreas cancer actually has the highest one-year and five-year mortalities of any cancer," says Sunil Hingorani, senior author of the study published in Cancer Cell.

    That high fatality rate has been something of a puzzle for researchers who study pancreatic cancer. Powerful chemotherapy drugs that kill off pancreas cancer cells in the laboratory are next to useless in living cancer patients.

    Scientists have observed how tumors in the pancreas, in effect, wall themselves off with a collagen material similar to scar tissue. That exerts pressure on the blood vessels that supply the tumor, collapsing many of them and restricting not just the flow of blood but also of chemotherapy drugs.

    "And so in this way, the tumor actually isolates itself completely from the circulation, and when we try to give drugs through the vein, they essentially bypass the tumor and instead go everywhere else," Hingorani says.

    So the problem may not be that the chemotherapy medicine doesn't work, but that it simply may not be able to reach its target.

    To find out, Hingorani and his colleagues used mice genetically engineered to stand in for human pancreatic cancer patients. They treated them with the standard chemotherapy drug, gemcitabine, plus the enzyme PEGPH20, which is designed to open up the collapsed blood vessels that supply the tumor.

    "We found that in essentially every animal that we tested, we saw the tumors shrink or at least stop growing," he said. "And we found that overall survival increased by about 70 percent — so not quite doubling, but just about."

    Of course, what works on mice doesn't necessarily work on people, so the researchers are beginning human trials. Hingorani says he is optimistic, but cautions that it will be a year or two before results are available from the tests with people.

    However, if all works as the researchers hope, not only would the chemotherapy be more effective, there may be fewer nasty side effects. That's because with more of the medicine actually reaching the tumor, doctors may be able to use less of the powerful chemotherapy drugs.
    7/12 DX stage 3 pan can (adenocarcinoma) @ 65 - borderline resectable
    8/12 - 10/12 Chemo (GTX) & Stereotactic Radiation
    12/12 Whipple - R0 margins, 2/29 nodes pos.
    1/13 - 5/16 Vaccine clinical trial - randomized to control group - vaccine showed no benefit
    2/13 - 8/13 Gemzar for 6 months
    Quarterly scans - no evidence of disease to 10/14 - spot on lung being watched - possible infection 2 months on antibiotics
    3/15 - spot larger - probable met - surgery planned
    4/15 - PET prior to surg - recurrence & lung mets - Surgery cancelled - EUS w/ FNA showed adenocarcinoma - Stage 4
    5/15 - 9/15 Folfirinox @ reduced dosage - Stopped treatment after 11 infusions due to neuropathy
    10/15 - 8/16 maintenance 5-fu every other week
    8/16 - stable disease on both CT and PET/CT - chemo holiday while other treatments explored
    9/16 - lung biopsy confirms pan can met,
    10/16 -NanoKnife to pancreatic bed -PET after Nano showed new met in hilar lymph nodes - SBRT to both lung & lymph
    4/17 - PET/CT showed significant disease progression, multiple lung mets, pancreatic bed tumor has grown
    5/17 - Started hospice care - striving for acceptance

    Stay busy and live life to the best of your ability.

  2. #22
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    I just learned about an exciting new pancreatic cancer trial being conducted by The University of Texas Southwestern Medical Center. In this cancer trial, David Boothman, PhD, is using the drug beta-lapachone to attack the enzyme NQO1. It turns out that people with pancreatic ductal adenocarcinoma tend to have a lot of NQO1 in the pancreas, and beta-lapachone kills NQO1 cells. It also turns out that healthy pancreatic cells have a lot of the enzyme catalase, which protects those healthy cells from the effects of beta-lapachone. Because catalase is not present in cancer cells, they have no protection from the effects of beta-lapachone, and the cancer cells die. As I understand it, that’s the general theory behind this cancer trial.

    For more details ref - [URL="http://www.empoweredpancreaticcancerpatient.com/promising-new-pancreatic-cancer-trial/"]http://www.empoweredpancreaticcancerpatient.com/promising-new-pancreatic-cancer-trial/[/URL]
    Last edited by Dattu; 04-11-2016 at 11:45 AM. Reason: typos

  3. #23
    Newbie Top User BobInBonita's Avatar
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    Here is a link to the ClinicalTials.gov description of the above trial of B-lapachone:
    [URL="https://clinicaltrials.gov/ct2/show/NCT02514031"]NCT02514031[/URL]

    It is a phase 1 trial (primarily looking at maximum tolerated dosage to be used in later phase 2 trials). There are two locations listed that will conduct the trial (Johns Hopkins and UTexas SW). The trial is only enrolling 20 patients who must have metastatic, recurrent, and unresectable PC.
    7/12 DX stage 3 pan can (adenocarcinoma) @ 65 - borderline resectable
    8/12 - 10/12 Chemo (GTX) & Stereotactic Radiation
    12/12 Whipple - R0 margins, 2/29 nodes pos.
    1/13 - 5/16 Vaccine clinical trial - randomized to control group - vaccine showed no benefit
    2/13 - 8/13 Gemzar for 6 months
    Quarterly scans - no evidence of disease to 10/14 - spot on lung being watched - possible infection 2 months on antibiotics
    3/15 - spot larger - probable met - surgery planned
    4/15 - PET prior to surg - recurrence & lung mets - Surgery cancelled - EUS w/ FNA showed adenocarcinoma - Stage 4
    5/15 - 9/15 Folfirinox @ reduced dosage - Stopped treatment after 11 infusions due to neuropathy
    10/15 - 8/16 maintenance 5-fu every other week
    8/16 - stable disease on both CT and PET/CT - chemo holiday while other treatments explored
    9/16 - lung biopsy confirms pan can met,
    10/16 -NanoKnife to pancreatic bed -PET after Nano showed new met in hilar lymph nodes - SBRT to both lung & lymph
    4/17 - PET/CT showed significant disease progression, multiple lung mets, pancreatic bed tumor has grown
    5/17 - Started hospice care - striving for acceptance

    Stay busy and live life to the best of your ability.

  4. #24
    Newbie Top User BobInBonita's Avatar
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    A potentially exciting article on treatment of stage 4 pancreatic cancer. Results have only been posted on the early phase 1 data, but it is moving into phase 2 based on those results. If the results are nearly as good they plan a larger phase 3 study.

    Patients recieved standard dose of gem/abraxane but with cisplatin added on. There was some concern over the side effects, but by going with the lowest cisplatin dose tested and monitoring patients so supportive care can be provided, they feel side effects can be controlled. Although only 10 patients were included in the phase 1 study, 80% showed a response. Among the 8 patients that showed a response, 2 had a complete response (NED), 6 had a partial response (tumor and markers shrunk). 1 patient also had stable disease, and 1 had disease progression.

    Here is a link to the "plain English" news report:
    [url]http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/[/url]

    Here is the ASCO abstract:
    [url]http://cancerres.aacrjournals.org/content/75/15_Supplement/LB-003?cited-by=yes&legid=canres;75/15_Supplement/LB-003[/url]

    And here is the ClinicalTrials.gov information on the trial:
    [url]https://clinicaltrials.gov/ct2/show/NCT01893801[/url]
    7/12 DX stage 3 pan can (adenocarcinoma) @ 65 - borderline resectable
    8/12 - 10/12 Chemo (GTX) & Stereotactic Radiation
    12/12 Whipple - R0 margins, 2/29 nodes pos.
    1/13 - 5/16 Vaccine clinical trial - randomized to control group - vaccine showed no benefit
    2/13 - 8/13 Gemzar for 6 months
    Quarterly scans - no evidence of disease to 10/14 - spot on lung being watched - possible infection 2 months on antibiotics
    3/15 - spot larger - probable met - surgery planned
    4/15 - PET prior to surg - recurrence & lung mets - Surgery cancelled - EUS w/ FNA showed adenocarcinoma - Stage 4
    5/15 - 9/15 Folfirinox @ reduced dosage - Stopped treatment after 11 infusions due to neuropathy
    10/15 - 8/16 maintenance 5-fu every other week
    8/16 - stable disease on both CT and PET/CT - chemo holiday while other treatments explored
    9/16 - lung biopsy confirms pan can met,
    10/16 -NanoKnife to pancreatic bed -PET after Nano showed new met in hilar lymph nodes - SBRT to both lung & lymph
    4/17 - PET/CT showed significant disease progression, multiple lung mets, pancreatic bed tumor has grown
    5/17 - Started hospice care - striving for acceptance

    Stay busy and live life to the best of your ability.

  5. #25

    VS-4718 trial

    VS-4718, an FAK inhibitor, to allow immunotherapy access to cancer cell microenvironment.

    [URL="https://clinicaltrials.gov/ct2/show/NCT02651727"]https://clinicaltrials.gov/ct2/show/NCT02651727[/URL]

    Article about concept:
    [URL="https://www.sciencedaily.com/releases/2016/07/160704145734.htm"]https://www.sciencedaily.com/releases/2016/07/160704145734.htm[/URL]
    DOB Sept. 1947. Prostate cancer Gleason 7 (3+4), PSA 5 in Oct 2010. Cryoablation Jan. 2011. Had some complications.
    Experienced nocturia, irritable bladder summer 2011. "Agent Orange"compensation from VA Oct 2011.
    PSA: .05 01/26/2012, .06 6/26/2012, .04 12/24/2012, .04 6/26/13, .05 1/27/14, .05 10/21/14, .04 10/15
    I am eating vegan mostly plus a little fish. Take some supplements.
    (Any advice given is the personal opinion of a layman and is not intended to replace the advice of a health professional.)

  6. #26
    Super Moderator Top User ddessert's Avatar
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    Gemzar/Abraxane/Cisplatin: 80% response rate

    It's hard to get me excited about chemotherapy clinical trials, but here is one I'm keeping a close look on.

    First, it was run out of the T-Gen clinic where Dr. Von Hoff did the landmark Gemzar/Abraxane study that has become our latest FDA-approved treatment. [URL="https://www.youtube.com/watch?v=z6ppjSvU118"]Youtube video here[/URL].

    Second, in their stage IV phase 1 trial, 8/10 (mostly treatment-naive) patients had >20% shrinkage of their tumors. That response rate is unheard-of in our cancer, but make sure you note that only 10 patients got the treatment. [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]ASCO post here[/URL].

    Third, the patients who saw dramatic responses saw them within 3 cycles, or 9 weeks.

    More specifically, there were 2 complete responses (NED), 6 partial responses (>20% tumor size reduction), 1 stable response (no shrinkage or growth), and 1 progressive disease.

    The [URL="https://clinicaltrials.gov/ct2/show/NCT01893801"]NCT01893801[/URL] phase 2 trial is continuing in Arizona with more patients and hopefully this will fill up and present more definitive results ASAP, because, wow.

    I note that all three drugs in this combination have been approved by the FDA and are used in various types of cancers. The combination is what is being tested for the first time. It might be possible for patients to get this prescribed to them off-label, outside the trial. I know of one who's tried at Duke and had no success. For those that try this, there is [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]this warning[/URL]:

    "Ms. Jameson and Dr. Borazanci are aware that oncologists may see these results and try this regimen on their own patients. Those doing so should be aware, said Dr. Borazanci. “This treatment requires a lot of attention. In our center, we are very responsive to the needs of our patients. A lot of supportive care is needed around this regimen,” he noted.

    "The clinicians’ biggest concerns have been the prevention of dehydration, neuropathy, and fatigue. They use intravenous fluids liberally. “It’s not been completely smooth sailing,” he acknowledged."
    BRCA2 3398del5
    Dec 2010 - back/abd pain
    May 2011 - Unresectable stage III, 2.5cm tumor
    Jun-Aug 2011 - Gem/Cis, 9 rounds
    Oct-Nov 2011 - Radiation+Xeloda, 25 days in 5 weeks
    Oct 2011-Sep 2012 - shrinking tumor
    Feb 2012 - National Familial Pancreatic Study
    Aug 2012 - Downgraded to stage IIA, PGP
    Sep 2012 - Whipple, T3N0M0, 0.5cm tumor, 0/16 lymph nodes
    Dec 2012 - Quebec PanCan Study
    Sep 2012-Nov 2017 - NED
    Mar 2013-present - NCT01088789
    @pancanology

  7. #27
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    Quote Originally Posted by ddessert View Post
    It's hard to get me excited about chemotherapy clinical trials, but here is one I'm keeping a close look on.

    First, it was run out of the T-Gen clinic where Dr. Von Hoff did the landmark Gemzar/Abraxane study that has become our latest FDA-approved treatment. [URL="https://www.youtube.com/watch?v=z6ppjSvU118"]Youtube video here[/URL].

    Second, in their stage IV phase 1 trial, 8/10 (mostly treatment-naive) patients had >20% shrinkage of their tumors. That response rate is unheard-of in our cancer, but make sure you note that only 10 patients got the treatment. [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]ASCO post here[/URL].

    Third, the patients who saw dramatic responses saw them within 3 cycles, or 9 weeks.

    More specifically, there were 2 complete responses (NED), 6 partial responses (>20% tumor size reduction), 1 stable response (no shrinkage or growth), and 1 progressive disease.

    The [URL="https://clinicaltrials.gov/ct2/show/NCT01893801"]NCT01893801[/URL] phase 2 trial is continuing in Arizona with more patients and hopefully this will fill up and present more definitive results ASAP, because, wow.

    I note that all three drugs in this combination have been approved by the FDA and are used in various types of cancers. The combination is what is being tested for the first time. It might be possible for patients to get this prescribed to them off-label, outside the trial. I know of one who's tried at Duke and had no success. For those that try this, there is [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]this warning[/URL]:

    "Ms. Jameson and Dr. Borazanci are aware that oncologists may see these results and try this regimen on their own patients. Those doing so should be aware, said Dr. Borazanci. “This treatment requires a lot of attention. In our center, we are very responsive to the needs of our patients. A lot of supportive care is needed around this regimen,” he noted.

    "The clinicians’ biggest concerns have been the prevention of dehydration, neuropathy, and fatigue. They use intravenous fluids liberally. “It’s not been completely smooth sailing,” he acknowledged."
    Just curious what is the result and the side effect if we are using NC6004 ( Nanoplatin ) in this Trial instead of cisplatin , maybe can reduce the side effect of cisplatin.

  8. #28
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    My dad is in the clinical trial HALO 301 which is Gemzar/ Abraxane plus PEGH20(the clinical trial which 2/3 participants receive). My dad is 77 yrs old and was diagnosed on New Years Day with stage 3 inoperable pancreatic cancer. We got approved for this trial since his tumors are high in HA content. We've completed two full cycles ;( 3 weeks on 1 week off each cycle) and have watched is cancer markers drop from 3,000 to 1500 to 400 which is where they are now. My dad has been in the hospital one week for the flu and another week for chemo toxicity to his lungs. We are taking a few weeks off from treatment and repeating his chest X-ray to see if he is able to continue with this treatment.
    I would be happy to answer any questions anyone might have regarding this clinical trial and our experience to date.

    ;320272]It's hard to get me excited about chemotherapy clinical trials, but here is one I'm keeping a close look on.

    First, it was run out of the T-Gen clinic where Dr. Von Hoff did the landmark Gemzar/Abraxane study that has become our latest FDA-approved treatment. [URL="https://www.youtube.com/watch?v=z6ppjSvU118"]Youtube video here[/URL].

    Second, in their stage IV phase 1 trial, 8/10 (mostly treatment-naive) patients had >20% shrinkage of their tumors. That response rate is unheard-of in our cancer, but make sure you note that only 10 patients got the treatment. [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]ASCO post here[/URL].

    Third, the patients who saw dramatic responses saw them within 3 cycles, or 9 weeks.

    More specifically, there were 2 complete responses (NED), 6 partial responses (>20% tumor size reduction), 1 stable response (no shrinkage or growth), and 1 progressive disease.

    The [URL="https://clinicaltrials.gov/ct2/show/NCT01893801"]NCT01893801[/URL] phase 2 trial is continuing in Arizona with more patients and hopefully this will fill up and present more definitive results ASAP, because, wow.

    I note that all three drugs in this combination have been approved by the FDA and are used in various types of cancers. The combination is what is being tested for the first time. It might be possible for patients to get this prescribed to them off-label, outside the trial. I know of one who's tried at Duke and had no success. For those that try this, there is [URL="http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/"]this warning[/URL]:

    "Ms. Jameson and Dr. Borazanci are aware that oncologists may see these results and try this regimen on their own patients. Those doing so should be aware, said Dr. Borazanci. “This treatment requires a lot of attention. In our center, we are very responsive to the needs of our patients. A lot of supportive care is needed around this regimen,” he noted.

    "The clinicians’ biggest concerns have been the prevention of dehydration, neuropathy, and fatigue. They use intravenous fluids liberally. “It’s not been completely smooth sailing,” he acknowledged."
    [/QUOTE]

  9. #29
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    Trial: nivolumab (N) + albumin bound paclitaxel (AP) + paricalcitol (P) + cisplatin (C) + gemcitabine (G) (NAPPCG) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC)

    Link: [url]https://clinicaltrials.gov/show/NCT02754726[/url]

    Abstract on early results here: [url]https://meetinglibrary.asco.org/record/155826/abstract[/url]

    Some early results were shared at the 2018 GI ASCO meeting a few days ago. 80% partial response rate(!). Builds on previous trial they did with gem/cisplatin and nab-paclitaxel that also had an encouraging response rate (mentioned earlier in this trial thread I believe). Link to information on that previous trial here: [url]http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.4_suppl.341[/url] and here: [url]http://www.ascopost.com/issues/april-10-2016/phase-ibii-study-reports-high-response-rates-seen-with-addition-of-cisplatin-to-regimen-for-advanced-pancreatic-cancer/[/url]
    August 2017 mom diagnosed with stage IV (spread to distant lymph nodes and small nodes in lungs)
    September 2017 3 rounds of FOLFIRINOX
    October 2017 scans showed no lung nodes, but then minimal tumor growth, time to switch chemos
    October 2017 one round of Gemcitabine/Nab-Paclitaxel
    Caris profile showed BRIP1 mutation (BRCA-ness?)
    Persuaded oncologist to add Cisplatin to regimen based on mutation and results of trial out of Honorhealth
    Cisplatin added to 2nd cycle of chemo and subsequent cycles
    12/4/17 Scan showed lymph node shrinkage around tumor, slight tumor shrinkage, no evidence of other metastatic disease
    Vitamin D (paracalcitol) added to mix per Honorhealth's experience/trials
    2/6/18 Scan showed lymph nodes and tumor continue to gradually shrink. Pancreatic duct back went from 6mm to 3mm.
    2/19/18 Positive test for pathogenic germline mutation BRIP1
    Continuing Honorhealth/Tgen protocol of Gem/Nab/Cisplatin with addition of Paracalcitol (synthetic vitamin D)

 

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