Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.

“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.

“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”

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Clinical Trial Eligibility Criteria a Growing Obstacle

Excerpt:

“Despite a decade-long call for simplification of clinical trials, the number of criteria excluding patients from participating in clinical trials for lung cancer research continues to rise.

“Researchers found a nearly 60 percent increase in exclusion criteria by reviewing 74 National Cancer Institute-sponsored lung   from 1986 to 2016.”

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Clovis Oncology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Rucaparib Prostate Cancer Development Program

Excerpt:

“Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. today announced an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment.

“Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca™ (rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).”

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New Study Aims to Extend TTFields Beyond Grade IV Brain Cancer Domain

Excerpt:

“The use of tumor treating fields (TTFields) as a treatment for patients with brain tumors has, thus far, largely been focused on in glioblastoma, but an upcoming trial aims to expand the use of the device to the grade III patient population, says Daniel O’Connell, MD.

“Currently, the device is only FDA approved for use in grade IV brain tumors, but O’Connell, a neuro-oncologist at UCLA’s David Geffen School of Medicine, anticipates the FDA will grant its approval for use in grade III tumors within the next 2 to 3 months.”

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For Cancer Patients, Newest Treatments Force the Ultimate Decision, with No Room for Error

Excerpt:

“Three weeks earlier she’d been done. Done with the chemo and the uncertainty and the fatigue that pinned her to a bed where her husband found her sobbing after he put the boys to sleep. “When can I just pull the plug?” she asked.

“And now Rachel Lefebvre, 43, and her husband, Fred, were here, at her oncologist’s office.

“First the doctor would tell them if a last-line chemo drug had slowed the breakaway growth of her liver tumors. It had, he said, and Fred instantly grasped his wife’s knee. Now, he told them, is the time to take their one shot at one of the most promising kinds of experimental cancer treatments, known as immunotherapy.”

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Clinical Trial Versus Standard Protocol: Why and How to Enroll in a Trial


My job at Cancer Commons is to help cancer patients better understand and make decisions about their treatment. Through our Ask Cancer Commons service, I also strive to inform patients about new drugs in trials that they can discuss with their oncologists. Sometimes, I explain the rationale behind a patient’s current or upcoming treatment, and sometimes I try to convince patients to actually get treated, rather than hope that a vegetarian diet and herbal supplements will cure their metastatic disease. Continue reading…


Advaxis Combination Trial with Merck Completes First Two Dose-Escalation Cohorts

Excerpt:

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (MRK), today announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

“The KEYNOTE-046 trial is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.”

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Video: Dr. Barbara Burtness on the Psychology of Talking to Patients About Enrolling in Clinical Trials

“Barbara Burtness, MD, professor of Medicine (Medical Oncology), Clinical Research Program Leader, Head and Neck Cancers Program, co-director, Developmental Therapeutics Research Program, Yale Cancer Center, discusses the psychology of talking to patients about being involved in a clinical trial.

“Burtness says on average, medical professionals should take about 4 minutes or longer to properly explain the clinical trial to their patients, as well as leave ample time for questions at the end of the conversation. She adds that patients should understand what the differences are between conventional therapies and investigational therapies are.”

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Super Patient: Janet Freeman-Daily Joins a Clinical Trial—and Beats the Odds on Lung Cancer


In March 2011, Janet Freeman-Daily was about to take a long family trip to China. She’d been coughing for a while, so she asked her doctor for an antibiotic as a precaution before leaving. Even so, she came back in May with a respiratory infection that wouldn’t go away.

Her doctor ordered an X-ray and then a CT scan. “Before I got home, they called and said they’d like to do a bronchoscopy,” Janet says. The scan revealed a 7-cm mass in her left lung, and biopsies showed it was non-small cell lung cancer (NSCLC) and that it had spread to several lymph nodes. Continue reading…