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CNTO 328 Shows Promise For Ovarian Cancer In Small Clinical Trial, Say U.K. Scientists.

Posted by Paul Cacciatore on April 7, 2009

British scientists have developed and clinically tested a drug that could prolong the lives of ovarian cancer patients. A clinical trial of the drug, codenamed CNTO328, has been carried out at the Centre for Experimental Cancer Medicine, which is part of Barts and the London School of Medicine and Dentistry. … The drug is an antibody which works by targeting a molecule called Interleukin 6, which is made by cancer cells and is vital to help them multiply, spread and develop their own blood supply. … “At the end of the trial, eight of the women were either stable or getting better. Their cancer had stopped growing. That doesn’t sound great, but in ovarian cancer that’s pretty good because [without the drug] the disease would have progressed in all of them,” said McNeish.

British scientists have developed and clinically tested a drug that could prolong the lives of ovarian cancer patients.  A clinical trial of the drug, codenamed CNTO328, has been carried out at the Centre for Experimental Cancer Medicine, which is part of Barts and the London School of Medicine and Dentistry.

Eight of the 18 women enrolled in the trial experienced tumor stabilization or shrinkage.  The investigators noted that the percentage of women who received clinical benefit from CNTO328 is an unusually high proportion for an experimental cancer drug study. Typically only between 5%  and 20% of participants secure any benefit from taking untried treatments, according to the investigators.

Iain McNeish, MA, Ph.D., MRCP, Professor of Gynecological Oncology, Honorary Consultant in Medical Oncology,  Deputy Director Centre for Experimental Cancer Medicine Centre for Molecular Oncology & Imaging, Barts and the London School of Medicine & Denistry

Iain McNeish, MA, Ph.D., MRCP, Professor of Gynecological Oncology, Honorary Consultant in Medical Oncology, Deputy Director Centre for Experimental Cancer Medicine Centre for Molecular Oncology & Imaging, Barts and the London School of Medicine & Denistry, London, United Kingdom

Professor Iain McNeish, a professor of gynaecological oncology at Barts hospital in London and chief investigator of the trial, said: “We have taken the drug from the laboratory into patients and the results are promising.  The hope with this group of patients was to slow down the progress of their ovarian cancer, improve the quality of their life and possibly make them live longer. We have been quite successful in doing that. If this becomes a treatment, this is a whole new approach to treating ovarian cancer.”

The drug is an antibody which works by targeting a molecule called Interleukin 6, which is made by cancer cells and is vital to help them multiply, spread and develop their own blood supply.  Interleukin 6 is found in many cancers but plays a key role in ovarian cancer’s movement into the abdomen. The antibody binds to the Interleukin 6, blocks its progress by ensuring that it cannot bind itself to the cancer cells to assist their growth and thus renders it harmless.

McNeish hopes that, if further trials confirm the drug’s potential, it could prove as effective in tackling ovarian cancer as Herceptin has been in breast cancer. CNTO328 works in a similar way to Herceptin, which has revolutionized breast cancer treatment in recent years. “The dream scenario is that a combination of the existing chemotherapy drugs and this type of antibody will be a big breakthrough and open up a new avenue for the treatment of ovarian cancer”, said McNeish.

The new drug is the result of a collaboration between Professor Fran Balkwill, an expert in cancer and inflammation at the Institute of Cancer, Barts and the London School of Medicine and Denistry, and a Dutch biotech company called Centocor, which is now owned by Johnson & Johnson.

Eighteen women with the disease from north-east London and Essex joined the trial which began in late 2007.  All 18 were expected to live for less than a year when they began receiving the drug because their cancer had returned after undergoing several courses of chemotherapy.  Ten women died but the health of eight women improved. Seven of those eight women are still alive.  “At the end of the trial, eight of the women were either stable or getting better. Their cancer had stopped growing. That doesn’t sound great, but in ovarian cancer that’s pretty good because [without the drug] the disease would have progressed in all of them,” said McNeish.

Annwen Jones, chief executive of the UK charity Target Ovarian Cancer, said there were too few drugs available to treat ovarian cancer because of a lack of research. “This early stage trial certainly shows promise, because it appears that the growth of tumors has been slowed down in a good proportion of the patients who took part in the study,” said Jones. “Women being treated for ovarian cancer could be forgiven for despair, particularly when they grow resistant to chemotherapy and there are no drugs that can get them over this hurdle. Research projects like this are vital if we are to develop desperately needed new treatments,” she said.

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11 Responses to “CNTO 328 Shows Promise For Ovarian Cancer In Small Clinical Trial, Say U.K. Scientists.”

  1. Michelle said

    Dear Paul

    Thank you so much for all of the effort you are making for us so far. I have emailed Professor Iain McNeish, lets hope I get a response, also I have emailed the email on the clinical trial site. I am praying that something can be done for my sister, she is taking morphine for the pain but at the moment this does not seem to be working but she is going to see her doctor tomorrow and hopefully he can prescribe something to relieve her pain. Just to mention the new chemo she has just started is Gemcitabine.

    Thank you once again for all of your advice, it really means a lot

    Regards Michelle

  2. Michelle said

    Dear Paul

    My sister was diagnosed with stage IV ovearian cancer 5 years ago and has had at most 6 months between chemos. Could you tell me if CNTO328 is recruiting in England still. My sister has been told she has less than a year and has had a lot of various chemo drugs she has 3 tumours in her abdomen now which slightly grew with her last type of chemo. I did go onto a website and she passsed initial criteria for Birmingham but have not heard anything since.

    Thanks Michelle

    • Dear Michelle,

      Please know that our thoughts and prayers are with you and your sister. It sounds like you and your sister have made prudent choices for treatment thus far, and your sister is very fortunate to have such a great advocate. As far as I know, the CNTO328 trial is still recruiting. Given that you already verified your sister’s eligibility through the Veritas Medicine website, I would take the following steps:

      1. Contact Professor Iain McNeish directly. Prof. McNeish is the lead investigator of the CNTO-328 clinical trial. His email is i.a.mcneish@qmul.ac.uk. Although I would email Dr. McNeish, I would also place a telephone call to the Barts and the London School of Medicine and Dentistry (where Prof. McNeish is located). The information is set forth below. I would try to speak with Dr. McNeish or his secretary directly and explain the urgency of your situation. Let him know that I referred you to him. If he (or his secretary) asks about me, just tell Dr. McNeish that I attended the Ovarian Clear Cell Cancer Symposium (at the invitation of Dr. David Huntsman) with him in June 2010. The Symposium was held at the University of British Columbia, Vancouver, Canada.

      Institute of Cancer
      Barts and The London School of Medicine and Dentistry
      Charterhouse Square
      London EC1M 6BQ
      School of Medicine & Dentistry Switchboard +44 (0)20 7882 5555
      Fax: +44 (0)20 7882 3888
      email: cancer@qmul.ac.uk

      2. If you don’t hear back from Dr. McNeish, try to contact one of the prinicipal investigators at the Centre for Experimental Cancer Medicine (CECM) (where the primary study is based). You can view a list of the prinicipal investigators by clicking here.

      3. If you do not receive a timely response from Prof. McNeish or another CECM investigator, I would contact Centocor Ortho Biotech Inc. Centocor is the U.S. manufacturer of CNTO-328. The general contact information for the Centocor corporate headquarters is as follows:

      Centocor Ortho Biotech Inc. (recently acquired by Johnson & Johnson)
      800 Ridgeview Road
      Horsham, Pennsylvania 19044
      USA
      Customer Communications Center: 00-1-800-457-6399

      If the main Centocor customer communications center is not helpful, contact the head of the Johnson & Johnson Oncology Group Communications directly to obtain the information that you require (Lisa Vaga, Oncology Group, Communication and Public Affairs, Johnson & Johnson, Telephone No. — 00-1-908-218-7316).

      4. If all of these methods above fail, contact me again and I will utilize another contact to obtain the information.

      Michelle, I hope this information is helpful. If you have any questions regarding the above-mentioned information, please feel free to contact me.

      Best Wishes, Paul

  3. shane fitzgibbon said

    Hi there, I was wondering if this trial is still available to ovarian cancer patients as my sister has stage 4 ovarian cancer which was discovered back in march 2007, she has had debulking operation and is currently on 3rd round of chemo, she is presently complaining of pain in the abdomen and I am anxious for her to have this particular drug as it may be her best hope of surviving this terrible disease, she lives in Ireland, thank you Shane

    • Shane, I am so sorry to hear about your sister. She is in our thoughts and prayers. Based on the CNTO-328 clinical trial summary, the trial is still open. Click here to view that summary. The good news is that the summary now lists three new trial locations in the U.K.: Southampton, Birmingham, and Edinburgh. The Birmingham and Edinburgh locations are not yet recruiting per the summary.

      I assume that the U.K. locations are being conducted by the Centre for Experimental Cancer Medicine (CECM), which is part of Barts and the London School of Medicine and Dentistry. The CECM conducted the initial study that is described in the Libby’s H*O*P*E*(tm) story above. I believe that the Southampton, Birmingham and Edinburgh clinical trial locations set forth in the trial summary represent facilities that are part of the CECM network (see map on CECM homepage by clicking on the blue CECM hyperlink above). Importantly, the CECM network map also sets forth a CECM facility located in Belfast, Ireland. Based on the foregoing, I would do the following:

      1. Try to contact Professor Iain McNeish directly. Prof. McNeish is the lead investigator of the CNTO-328 clinical trial. His email is i.a.mcneish@qmul.ac.uk. The general contact information for the Barts and the London School of Medicine and Dentistry (where Prof. McNeish is located) is as follows:

      Institute of Cancer
      Barts and The London School of Medicine and Dentistry
      Charterhouse Square
      London EC1M 6BQ
      School of Medicine & Dentistry Switchboard +44 (0)20 7882 5555
      Fax: +44 (0)20 7882 3888
      email: cancer@qmul.ac.uk

      Once you contact Prof. McNeish, I would ask him the following questions:
      (i) confirm that the CNTO-328 clinical trial is still recruiting new patients in the UK;
      (ii) determine the start date(s) upon which the Birmingham and Edinburgh clinical trial locations will begin recruiting; and
      (iii) determine if it is possible for your sister to enroll in the CNTO-328 clinical trial at the CECM Belfast, Ireland location.

      Be aware that your sister must satisfy the CNTO-328 clinical trial entrance criteria prior to enrollment in that trial. The trial entrance criteria (and exclusion criteria) is listed in the CNTO-328 clinical trial summary hyperlinked above. Print out a copy of the summary and provide it to your sister’s doctor. He or she should be able to tell you based on her case whether or not your sister would qualify.

      2. If you do not receive adequate answers to the questions above from Prof. McNeish, I would contact Centocor Ortho Biotech Inc. Centocor is the U.S. manufacturer of CNTO-328. The general contact information for the Centocor corporate headquarters is as follows:

      Centocor Ortho Biotech Inc. (recently acquired by Johnson & Johnson)
      800 Ridgeview Road
      Horsham, Pennsylvania 19044
      Customer Communications Center: 00-1-800-457-6399

      If the main Centocor customer communications center is not helpful, contact the head of Centocor communication directly to obtain the information that you require (Kassy McGourty, Vice President, Communication and Public Affairs, Centocor Ortho Biotech Inc.,Telephone No. — 00-1-215-325-4250).

      Shane, if you follow the steps above, you should be able to obtain all of the information necessary to allow your sister to make an informed decision about treatment location. I do not know where you live in Ireland (i.e., North, South or Central) and I do not know if you sister if fit for travel. But, obtainment of the information as noted above, should allow her (and you) to make the best possible decision.

      If you have any further questions, please do not hesitate to contact me. Best regards, Paul

  4. Sue Halse said

    Dear Paul,
    I was diagnosed with 3C Ovarian Ca in March 2008.Following bebulking surgery I completed chemo ( Carboplatin, Paclotaxil 23rd Sept 2008 and a trial with Bivasuzamab which was completed April 2009).
    It appears I got to about 6 months before my CA125 started to increase and am to have a scan next week.
    I live in New Zealand and would be interested to hear if there is anyway I can particpate in the CNT0328 trial.I look forward to your reply.
    Kind Regards
    Sue Halse

    • Dear Sue,

      Thank you for the inquiry. Unfortunately, all of the information that I have regarding the clinical trials for CNTO 328 is set forth in the April 7, 2009 Libby’s H*O*P*E* posting and the comments set forth below the post. Click here to view the CNTO 328 post and related comments (scroll down the page to view comments).

      If you review my comments to Nitin and Carla re CNTO 328, you will find additional information relating to the CNTO 328 clinical testing locations and contact information for Centocor Ortho Biotech Inc. (the company that is conducting the CNTO 328 clinical trials. Please be aware that Centocor Ortho Biotech Inc. was recently acquired by Johnson & Johnson). Unfortunately, New Zealand is not listed as a test location. Despite that fact, you (or your doctor) should contact Centocor directly to determine if there is anyway that you can participate in the trial. If you have any problem contacting Centocor, please let me know. You can also contact the doctors listed in the Libby’s H*O*P*E* April 7, 2009 post by clicking on their names (e.g., Fran Balkwill).

      I also note that the only drugs that you have tried to date are carboplatin (Taxotere), paclitaxel (Taxol) and bevacizumab (Avastin). Was bevacizumab used as a monotherapy in your trial, or in combination with other drugs? You have not tried pegylated liposomal doxorubicin or topotecan. As a precaution, I am providing you with a list of all clinical trials in Australia that are either recruiting or about to recruit ovarian cancer patients. Click here to review those trials. This search included a few breast cancer trials so simply ignore them. Unfortunately, my search for open clinical trials in New Zealand only identified five trials that either did not apply to you or included drugs that you have already tried.

      How was the six month period until CA125 increase calculated? Is it six months after completion of carbo + paclitaxel, but during administration of bevacizumab? In the U.S., an ovarian cancer patient is generally considered platinum drug (i.e., cisplatin, carboplatin, etc.) refractory if the cancer recurs within six months after completion of the final dose of platinum drug. The patient is considered platinum drug resistant if the recurrence occurs between six months and one year. The patient is considered platinum drug sensitive if the the recurrence occurs after 12 months. These categories can provide some insight when reviewing medical abstracts, etc. because certain drugs are targeting patients in one or more of the three general categories.

      Finally, keep in mind that a rising CA125 is not definitive until you obtain your scan results. I hope this information provides a start and if you have additional questions, please feel free to contact us. Keep the faith and keep fighting, and we’ll keep you in our thoughts and prayers.

      Best,

      Paul

  5. Mr. Nitin Karandikar said

    Dear Sir,

    I require information & availability option / source in India for abovementioned Chemo drug CNTO328.
    My wife is sufferring from Ovarian cancer, which has recurred thrice& metastised.
    Initially ( may-2006 to Oct-2006), 3 cyles of Chemo-followed by total histerectomy & De-bulking of Ovarion mass-followed by 3 chemo(Carboplatin & taxol)as carried out.
    Subsequently, on recurrence (thrice), several Chemo drugs have been tried out, till date.

    Please contact me on how my wife can participate in a clinical study for this drug or get this drug in India.

    • Dear Nitin,

      I am sorry to hear about your wife. Please let her know that she is in our thoughts and prayers. Currently, there are five open clinical trials that are testing CNTO-328. CLICK HERE to view the five open trials. Only one out of the five open clinical trials is enrolling ovarian cancer patients. CLICK HERE to view the clinical trial entitled, A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors.

      The CNTO-328 clinical trial for solid tumors, including ovarian cancer, lists three trial locations: (1) Philadelphia, Pennsylvania, United States, (2) Villejuif, France, and (3) Barcelona, Spain. It is my understanding that the Philadelphia, Pennsylvania trial location is the Abramson Cancer Center of the University of Pennsylvania. As you can see, there are no Indian locations listed for this trial.

      The remaining four open CNTO-328 clinical trials are testing the drug against cancers other than ovarian cancer. However, I should note that the trial entitled, A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects With Relapsed or Refractory Multiple Myeloma, lists 3 testing locations in India. The Indian locations listed are Delhi, Ahmedabad, and Hyderabad. The Indian locations are not enrolling patients yet, but presumably, will be in the near future.

      My thought is that you or your doctor should contact the corporate U.S. headquarters of Centocor, Inc. and request that your wife be included in the CNTO-328 solid tumor clinical trial (which includes ovarian cancer patients), with your wife’s participation to occur at one of the Indian locations listed above. I do not know if that is possible, but I would try anyway. The only obstacle that I foresee is that the Indian locations are testing CNTO-328 against multiple myeloma (not ovarian cancer) and the trial investigators may have to request approval from the appropriate Indian authorities to test the drug in a patient with ovarian cancer. To the extent that the Indian regulatory authorities simply approve the drug itself, rather than the disease treated, you may be ok. Centocor may be able to provide the Indian locations with the solid tumor (incl. ovarian cancer) clinical trial protocol and allow your wife to participate in that trial at one of the Indian locations. Centocor is overseeing all worldwide CNTO-328 clinical trials and may figure out a way in which your wife can get access to the drug within the context of a clinical trial without having to travel outside of India.

      The contact information for Centocor is listed below. I would first use the medical information toll-free number below. It would probably be better if your wife’s doctor contacted Centocor because they may be more willing to speak with a healthcare provider.

      Corporate Headquarters
      Centocor, Inc.

      800/850 Ridgeview Drive
      Horsham, PA 19044
      Main Phone 00+1+610-651-6000
      Main Fax 00+1+610-651-6100

      Centocor Medical Information
      00+1+800-457-6399 (toll free number)

      Although you want to obtain access to CNTO-328, I performed an additional search to find all open ovarian cancer clinical trials in India. The search discovered three open ovarian cancer clinical trials. CLICK HERE to view the open ovarian cancer clinical trials being conducted in India. Unfortunately, the search pulled up one breast cancer clinical trial. Simply ignore it. If your wife has not used the drugs being tested in these clinical trials, they represent another alternative for her.

      I hope this information is helpful. If you have additional questions, please feel free to contact us through the Libby’s H*O*P*E* website (click on the homepage “Contact” tab or simply continue to comment under the CNTO-328 posting). And, keep the faith and keep fighting on behalf of your wife!

      Best,

      Paul

  6. Carla Thompson said

    Hi,
    My name is carla. I am 48 and have stage IV ovarian cancer. I was treated with taxol and carboplatin. I obtained remission for 9-12 months. My cancer is back. I have had serial CA125 test and have slowly moved to 112. My CT scans show cancer growth in my pelvic lymph nodes. I am interested in clinical trials and this new drug. Please contact me on how I can participate in a clinical study for this drug or get this drug in the US.
    Thank you,
    Carla Thompson

    • Hi Carla,

      Thank you for your comment. My research indicates that there is one trial that is using CNTO328. The trial is entitled, “A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors.” The clinical trial protocol indicates that testing of the drug will occur in Villejuif, France, Barcelona, Spain and Philadelphia, Pennsylvania. The French and Spanish locations are currently recruiting. The Philadelphia, Pennsylvania is not yet recruiting. The drug is made by Centocor Ortho Biotech Inc. I tried calling the Centocor corporate headquarters today, but the information line was closed for the day (8:30 A.M. – 5:00 P.M. E.D.T.). I provided the relevant Centocor contact information below:

      Corporate Headquarters
      Centocor, Inc. (now Centocor Ortho Biotech Inc.)
      800/850 Ridgeview Drive
      Horsham, PA 19044
      Main Phone (610) 651-6000
      Main Fax (610) 651-6100

      Medical Information
      (800) 457-6399

      Please feel free to contact the headquarters if you prefer. I am assuming that the Philadelphia location will be at the Abramson Cancer Center of the University of Pennsylvania or Fox Chase Cancer Center. Once I find out, I will post the information under the original Libby’s H*O*P*E* post regarding CNTO328. I will also post the CNTO328 clinical trial protocol under that same post.

      Carla, I hope this information is helpful. Our thoughts and prayers are with you. Please feel free to review Libby’s H*O*P*E* for additional novel therapies as many have been discussed over time. You can search by drug name if you know it, or simply click on the “Categories” button located on the homepage left sidebar and click again on the category “Novel Therapies“. You also should review the drugs listed under the post relating to the 2008 ASCO Annual Mtg Ovarian Cancer updates. I trust this information is helpful. Please let me know if you have any further questions. Keep the faith and keep fighting!

      Best, Paul

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