Pharmaceutical Company Completes Enrollment for Phase 1B Trial for Mesothelioma

ResearcherIf you attended our International Symposium on Malignant Mesothelioma in March of this year, you may recall the buzz of excitement that coursed throughout the scientific sessions. This buzz sparked excitement throughout the entire mesothelioma community, as we discussed advances in science, the needs of those affected by this disease, and the work being done to spur the movement of drugs through the clinical trial process.

Recently, Aduro Biotech issued a press release announcing the completion of enrollment in the Phase 1b clinical trial of its novel immunotherapy, CRS-207. I took the opportunity to call and congratulate Steve Isaacs, the chairman, president, and CEO of Aduro Biotech, on his initial trial results and his plan to move this drug along quickly and offer it globally in the Phase 3 setting.

It is exciting to see plans to jump from a Phase 1b directly to Phase 3 based on what was agreed to be compelling data by the FDA.

Patients treated on the Phase 1b study received 2 doses of CRS-207, a vaccine that utilizes the listeria virus and mesothelin as a target to gain entry into the cell. Patients then went on to receive standard of care pemetrexed/cisplatin every three weeks for 6 courses. If patients were stable or responded to the aforementioned therapy, they were then placed on a maintenance regimen of vaccinations every 8 weeks until progression.

Interim data was presented at a large scientific conference and demonstrated that in the 32 evaluable patients treated on this clinical trial, disease control was observed in 94%, which included a 60% partial response, and 34% experiencing stable disease.

The study will remain open to chemotherapy naive patients (patients who have never received chemotherapy for their mesothelioma) while the plans for the Phase 3 trial continue.

To read more about the CRS-207 study results, click here. To listen to an interview that we held with Steve Isaacs regarding the CRS-207 clinical trial, click here.

Using Herbs and Dietary Supplements During Mesothelioma Treatment

SpicesOver the last several year or so, a number of people have posted information about various supplements they favor, both for general health and, occasionally, as specific alternative remedies meant to bolster cancer treatment or prevention.  A number of our mesothelioma warriors have used yoga or stretching regimens to aid in post-surgical tissue relaxation, and others employ meditation or focused cognition to aid in mood and pain management. These non-invasive techniques have conferred varying levels of positive results, and pose no particular interactive problems with standard oncology therapy. Others, however, use one or more complementary therapies (e.g., naturopathy, homeopathy) or supplements (e.g., ginseng, green tea extracts), which could cause interactions with standard treatment if the proper care is not taken. Here, we provide some reference material to help anyone considering using such therapies or supplements.

A wealth of reputable and relevant information is easily available. For example, the professionals at Memorial Sloan Kettering Cancer Center (MSKCC) have a botanical expert pharmacist who monitors current science regarding herbs, botanicals, and other supplements. This is part of MSKCC’s Integrative Medicine Services. More information is available here.

Some herbs and dietary supplements are known to be detrimental to standard cancer treatment efficacy. One thing all reliable sources agree upon is that, before you start using any form of supplement or complementary medical treatment, you should tell your physician what you are considering.

MSKCC writes: “It’s important to tell your doctor or another qualified professional that you are using a dietary supplement. The reason for this is that an active ingredient in the product could interact with — increase or lessen — the effect of other medicines you’re taking.  People undergoing treatment for cancer should not receive any dietary supplements unless they’re prescribed by a doctor or given as part of a clinical trial that’s received [IRB] approval.”

NCI, in its Complimentary Alternative Medicine material, agrees: “Tell your doctor if you’re taking any dietary supplements, no matter how safe you think they are. This is very important. Even though there may be ads or claims that something has been used for years, they do not prove that it’s safe or effective.”

MD Anderson is in line in this herbal supplements article: “[Y]ou should approach herbal supplements with caution and speak with your doctor before taking any, whether you’re considering a pill, capsule, tablet or liquid form.”

The second important thing each of these expert facilities makes clear is that supplements – including herbs, vitamins, manufactured powdered weight controls, steroids, and all other over-the-counter materials are unregulated. The FDA treats supplements as foods. This means it does not verify any label claims (other than prohibiting specific disease prevention assertions). These materials are not subjected to clinical trials as they are understood in pharmaceutical development, and there is no control over additives, purity or the production methods.

Some manufacturers’ studies assert benefits in cancer treatment from use of their supplements. However, these are not the randomized, double blind studies we know as the gold standard for scientific study of new therapies. NCI and the National Center for Complementary and Integrative Health have begun clinical trials on a limited number of complementary therapies, but that data is still in development. The list and overview of these studies is available here.

If your research and medical team’s review lead you to try any of the hundreds of supplements advertised as health support, it is sensible to begin with a minimum dose. If the herb or compound neither helps nor hurts, you can slowly increase the amount or frequency of use. A measured approach will give you, and the physicians checking your blood analyses and scans, a better opportunity to detect any adverse effects before they become severe. Similarly, you can determine whether positive effects are amplified by increased dosage.

The following resources can provide you with additional information:

To read more about complementary and alternative medicine pertaining to mesothelioma patients, click here.

Benefits, Privacy, and Implementation of the Mesothelioma Patient Registry

Doctor speaking to patientLast week, we announced the important news that Congressman Katko introduced in Congress a bill to create a mesothelioma registry. You can read the news announcement here, and the full text of the bill here.

The creation of a registry for mesothelioma is crucial for the advancement of the mesothelioma science and development of effective treatments for this cancer. Other conditions, diseases, and cancers have seen incredible progress and increased life expectancy of their patients as a result of registry implementations. Patient registries have played a crucial role especially for diseases that are considered rare and for which scientists have a difficult time accessing enough data to conduct their research (or, for example, for which it is difficult to find enough patients to enroll in clinical trials in order to complete them). Researchers around the world need disease registries to bring together information about relatively rare diseases, such as mesothelioma. To that end, the Global Rare Diseases Patient Registry Data Repository (GRDR®) is a process that allows the creation of a registry for any rare disease population.  The needs and background are explained here by the NIH.

The language in the ‘Mary Jo Lawyer-Spano Patient Registry Act of 2015’ states:

The Secretary shall ensure that privacy and security protections applicable to the registry under this section are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009).”

The goal of a patient registry is to provide scientists with information they need to advance their research. However, this information is strictly safeguarded and only made available to scientists through a process by which they have to apply and demonstrate their particular relevant and valid need for these data. Also, all data is de-identified, meaning that patients’ names are stripped away from other information, and are instead replaced by unique numbers.

De-identification is the process used to prevent a person’s identity from being connected with information. Common uses of de-identification include human subject research for the sake of privacy for research participants.

The language in the bill itself requires that the registry be created in consultation with the following experts in mesothelioma and registry creation:

“(1) epidemiologists with experience in disease surveillance or registries;
“(2) representatives of national voluntary associations that focus on mesothelioma or have demonstrated experience in research, care, or patient service for mesothelioma;
“(3) health information technology experts or other information management specialists;
“(4) clinicians with expertise in mesothelioma; and
“(5) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.

General Patient Registry Information
To learn more about patient registries, please visit the following links on the National Institutes of Health (NIH) website:

Registry FAQs by the National Institutes of Health

How Do Registries Work?

Take action now, and ask your congressional representative to support this bill!

NIH to Start Enrollment for Precision Medicine Research

Patient ResearchIn his most recent State of the Union address, President Obama announced a bold new research effort to revolutionize how we improve health and treat disease. According the White House website, the Precision Medicine Initiative, as it’s called, will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

Last week, we learned that the one million patient research cohort at the National Institutes of Health (NIH) could begin enrolling patients in the next fiscal year.

As noted by the NIH, “Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Many efforts are underway to help make precision medicine the norm rather than the exception.”

The NIH is currently finalizing a plan for the cohort that will be reviewed by their research advisers and then must receive a sign-off from NIH Director Francis Collins.

Kathy Hudson, NIH’s director for science, outreach, and policy, believes the funding for the cohort will be approved by Congress, noting that Senate and House appropriators will invest $200 million for the Precision Medicine Initiative.

In addition to necessary funding, the cohort initiative will require policy updates, including those for protection of human research participants. Also, patient access to fully interoperable electronic health records will need to be improved.

As the original Politico article notes, “Hudson said NIH is working with the Senate to include any necessary policy updates for the initiative into its biomedical reform legislation. The chamber’s work is expected to ultimately synch with the House’s recently passed 21st Century Cures bill.”

For more information on precision medicine and the Precision Medicine Initiative, visit

A Summary of Mesothelioma Studies from ASCO 2015

MicroscopeBy Hedy Lee Kindler, MD,  University of Chicago

The American Society of Clinical Oncology meeting was held from May 29 – June 2, 2015 in Chicago. About 30,000 attendees from across the world gathered to discuss the latest research advances in all types of cancer, making this the largest, most important oncology meeting of the year. This was a particularly exciting meeting for those of us interested in mesothelioma. I’ve summarized 3 of the most prominent studies below.

MAPS: A randomized trial of pemetrexed, cisplatin with or without bevacizumab. This oral abstract, presented by Dr. Gerard Zalcman on behalf of the French Cooperative Thoracic Intergroup (IFCT), was clearly the star of the show for those of us who care about mesothelioma. This study is important because it is the first randomized trial in over a decade to show that a new drug improves survival in mesothelioma patients. Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), which is highly expressed on mesothelioma. Think of it as a drug that targets the blood vessels that feed tumors (angiogenesis). Bevacizumab (the trade name is Avastin) is already FDA approved in multiple cancers, including colon cancer and lung cancer. In the MAPS trial, all 448 patients received standard chemotherapy with pemetrexed plus cisplatin, and half of the patients were randomized to also receive bevacizumab with each dose of chemotherapy. After completing 6 cycles of chemotherapy, patients on the bevacizumab arm also received bevacizumab by itself, every 3 weeks until their cancer started to grow. The time for cancer growth to occur (progression-free survival) was about 2 months longer in the bevacizumab arm (9.59 vs. 7.48 months). Patients treated with bevacizumab also lived almost 3 months longer (18.82 vs. 16.07 months). The addition of bevacizumab did not make patients feel worse (it did not worsen quality of life), although it did cause increased side effects such as bleeding, high blood pressure, and blood clots. Because there was an improvement in survival with the experimental treatment, it is possible that this trial could lead to FDA approval of bevacizumab for mesothelioma—stay tuned!

NGR015: Randomized trial of investigator’s choice of chemotherapy with or without NGR-hTNF. Oral presentations at ASCO are only for the large randomized trials. At most ASCO meetings there are no mesothelioma presentations; this year, there were two! The second oral presentation was by Dr. Rabab Gaafar from Cairo, Egypt on behalf of an international group of investigators. All 400 patients on this trial previously received pemetrexed. They were randomized to receive either NGR-hTNF (another drug that targets angiogenesis) or placebo (sugar water).  In addition, patients could receive chemotherapy either with gemcitabine, vinorelbine, or doxorubicin, or no chemotherapy at all. Unfortunately, the addition of NGR-hTNF to chemotherapy did not affect how long the cancer was controlled, or how long the patients lived. Data is being analyzed to see if certain characteristics might predict which patients might benefit from this drug.

Mesothelin targeted immunotherapy CRS-207, plus pemetrexed/cisplatin chemotherapy. Dr. Raffit Hassan from the National Cancer Institute updated the results of this ongoing trial in a poster presentation. Mesothelin is highly expressed on the surface of mesothelioma. CRS-207 is a vaccine that increases the immune response against mesothelin, and may enhance the activity of chemotherapy. In this study, 2 doses of CRS-207 were given before pemetrexed and cisplatin, as well as after completion of 6 cycles of chemotherapy. Encouraging activity was observed: 60% of patients had tumor shrinkage, and another 34% had disease that did not grow. Thus 94% of patients had disease that was controlled with this experimental vaccine plus chemotherapy. This is much better than would be expected with chemotherapy by itself. Based on these encouraging results, a randomized study to test this combination compared with standard chemotherapy is in development.

Hedy Lee Kindler, MD, an internationally recognized authority on the treatment of mesothelioma, is a Professor of Medicine and the Director of the Mesothelioma and Gastrointestinal Oncology Programs at the University of Chicago. Dr. Kindler is a Past President of the International Mesothelioma Interest Group. She was a member of the Science Advisory Board of the Mesothelioma Applied Research Foundation from 2001-2014, and remains active with the Foundation.  Dr. Kindler chairs the Mesothelioma Subcommittee of the Alliance for Clinical Trials in Oncology, a national cancer clinical trials group. Her research focuses on the investigation of novel agents for the treatment of mesothelioma. Patients from throughout the United States come to Dr. Kindler’s Mesothelioma Clinic at the University of Chicago for her expert care and to participate in her many clinical trials. Dr. Kindler has been listed repeatedly in Best Doctors in America, America’s Top Physicians, America’s Top Doctors for Cancer, and Best Doctors in Chicago.