Patient’s Perspective: The Importance of Clinical Trials

Update:  We are deeply saddened to report that Neil passed away on July 29, 2015. It is a privilege to share his story and keep his memory alive.

Neil Schiffman has lived as healthy a life as one can live. An avid cycler and triathlon participant well into his 60s, Neil was visiting Arizona in April 2011 when he began to cough. The cough mimicked the symptoms of exercise-induced asthma, so at first he thought nothing of it. When the cough failed to disappear, he visited his pulmonologist, who suspected bacterial pneumonia. Meanwhile, Neil’s legs and feet began to swell–he went from wearing a size 10 shoe to a size 14. Alarmed, he had an X-ray and a CT scan, which revealed a mass identified as a neoplasm. He was referred to an oncologist, who delivered the bad news in June: Neil had stage IV non-small cell lung cancer (NSCLC). Continue reading…

ASCO: Sulforaphane in Prostate Cancer Found Worthy of Further Investigation

“Treatment with 200 µmol per day of sulforaphane for 20 weeks was “feasible, safe,” and inhibited histone deacetylase (HDAC) function in a single-arm study of 20 patients who had non-castrate biochemical (PSA)-recurrence of prostate cancer despite surgery or radiation (Abstract 5017). Findings were reported by Joshi J. Alumkal, MD, of the Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon. Sulforaphane is a constituent of cruciferous vegetables such as broccoli, which are “strongly associated with lower prostate cancer risk,” explained Alumkal. In preclinical studies sulforaphane has exhibited antineoplastic effects in multiple tumor models.”

New Chaperone-Targeting Ganetespib Prolongs Survival in Advanced Lung Cancer

Adding the novel heat shock protein (HSP)-90 inhibitor ganetespib to docetaxel in salvage therapy is associated with prolonged overall survival (OS) compared to docetaxel alone among patients diagnosed with advanced adenocarcinoma lung cancer, report authors of the large randomized, first-in-class phase 2 GALAXY-1 clinical trial, presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.”

Another Anti-PD1 Immunotherapy Shows Promise for Melanoma Patients

Following in the footsteps of positive results for the drug nivolumab, another anti-PD1 antibody, lambrolizumab (formerly MK-3475), is also showing promising activity in melanoma. At the annual meeting of the American Society of Clinical Oncology, Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, presented data from a large, 1,000-plus patient phase I trial that also included other cancer types. Continue reading…

ASCO: Enzalutamide Monotherapy in Prostate Cancer Achieves ‘High Response Rate, Marked PSA Decline'

“Monotherapy with enzalutamide (Xtandi) achieved a “high PSA response rate and marked PSA decline” in patients with hormone-naïve prostate cancer after 6 months in a single-arm, multicenter phase II study, reported Matthew Raymond Smith, MD, PhD, of the Massachusetts General Hospital Cancer Center, Boston (abstract 5001). Efficacy was similar to castration, but in contrast with castration, bone mineral density (BMD) remained stable and metabolic variables, including fat body mass, lipid, and glycemic profiles, were not substantially impacted by enzalutamide over the 6-month study period.”

A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor, in Patients with Advanced Solid Tumors

“Purpose: To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and pharmacokinetic and pharmacodynamic profile of quisinostat, a novel hydroxamate, pan-histone deacetylase inhibitor (HDACi).”

Multicenter, Randomized Phase II Trial of GM-CSF (GM) Plus Ipilimumab (Ipi) Versus Ipi Alone in Metastatic Melanoma: E1608

“CTLA-4 blockade and GM secreting tumor vaccine combinations demonstrate therapeutic synergy in multiple preclinical models. GM has activity in prostate and ovarian carcinoma and is being evaluated in phase III adjuvant trials for melanoma and lymphoma. GM enhances dendritic cell activation and potentiates antitumor T and B cell responses. GM may induce regulatory immune responses. A key issue is whether systemic GM might synergize with CTLA-4 blockade.”

Exelixis Announces Presentation of Updated Phase 2 Data for Cabozantinib in Men with Heavily-Pretreated Metastatic Castration-Resistant Prostate Cancer

“Exelixis, Inc. (NAS:EXEL) today announced the presentation of updated interim data from 144 docetaxel-pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases treated with cabozantinib in an ongoing non-randomized expansion (NRE) cohort of its phase 2 randomized discontinuation trial.”

ZIOPHARM Announces Presentation of Updated Results From Ad-RTS-IL-12 Phase I Study in Advanced Melanoma at the 2013 ASCO Annual Meeting

“ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today announced updated results from the Phase 1 study in advanced melanoma using Ad-RTS-IL-12, a novel DNA-based therapeutic candidate. Findings were presented in a poster presentation at the 2013 American Society for Clinical Oncology (ASCO) Annual Meeting being held May 31 – June 4, 2013 at McCormick Place in Chicago, IL.”