Tag Archives: Virginia G. Piper Cancer Center Clinical Trials

clinical research advantage - vaccines

TGen-Scottsdale Healthcare battle tumor growth

The safety and preliminary efficacy of a new class of tumor fighting drugs were reported by Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the Translational Genomics Research Institute (TGen).

Early results from the phase I, first in-human study of an RNA interface (RNAi) drug were announced during the American Association for Cancer Research (AACR) Annual Meeting 2013, April 6-10, in Washington, D.C. The drug, TKM-080301 (also known as TKM-PLK1) is being developed by Tekmira Pharmaceuticals Corporation.

The study was conducted at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with TGen. It found that the RNAi drug acts by silencing the PLK1 gene involved in tumor growth and can be safely administered in humans.  Most patients tolerated the drug well; some showed therapeutic benefit.

“RNAi therapies are a unique approach to cancer treatment as they have the potential to ‘turn off’ the genes’ coding for proteins involved in cancer cell division,” said Dr. Ramesh K. Ramanathan, Medical Director of Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and deputy director of the Clinical Translational Research Division of TGen. “Using a lipid nanoparticle, the RNAi drug can be delivered to a cancer cell to block the expression of specific proteins involved in tumor growth.”

TKM-080301 targets a specific gene called polo-like kinase 1 (PLK1), which codes for a protein involved in tumor cell growth. Prior research has shown that high levels of PLK1 are present in many types of cancer, including many of the more aggressive forms.

“Our preclinical results have shown that by decreasing PLK1 levels in cancer cells, we can stop tumor growth and kill the cancer cells,” Dr. Ramanathan said.

He and his colleagues have been enrolling patients with advanced solid tumors or lymphoma into the ongoing multicenter, open-label, dose-escalation study. Sequential cohorts of three to six patients have been assigned to escalating doses of TKM-080301 as a 30-minute intravenous infusion. To date, the researchers have assigned 23 patients to the drug at doses ranging from 0.15 mg/kg per week to 0.9 mg/kg per week.

The most common drug-related adverse events have been mild to moderate and include fever, chills, nausea, vomiting and fatigue. Dose-limiting toxicities were observed at the 0.9 mg/kg per-week dose. One patient with a history of asthma experienced shortness of breath and hypoxia; another patient had thrombocytopenia. The researchers subsequently reduced the maximum dose to 0.75 mg/kg per week.

Two patients have been assigned to TKM-080301 for more than six months and have shown no evidence of cumulative toxicity. One of these patients has stable disease and the other has a durable confirmed partial response.

“RNAi therapies, such as the one used in our study, have the potential to make a significant and broad impact on how we treat cancer because we have the ability to target virtually any protein involved in the disease,” Ramanathan said. “This approach has the potential to augment the currently available cancer treatments to improve outcomes for the patient.”

clinical research advantage - vaccines

TGen, Scottsdale Healthcare study may help pancreatic cancer patients

A multi-center Phase III clinical trial demonstrates that Abraxane (nab-paclitaxel) plus gemcitabine is the first combination of cancer drugs to extend survival of late-stage pancreatic cancer patients compared to standard treatment.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was led by physicians from Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

Their findings show that Abraxane plus gemcitabine was well tolerated and resulted in clinically meaningful outcomes compared to gemcitabine alone, the current standard of care. The study abstract was released today and the data will be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers annual meeting Jan. 25 in San Francisco.

“We are ecstatic that this clinical trial of Abraxane plus gemcitabine improves survival for patients with advanced stage IV pancreatic cancer,” said Dr. Daniel Von Hoff, international lead investigator for MPACT, chief scientific officer for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, and TGen’s Physician-In-Chief. “It once again demonstrates that laboratory science based medicine can make a difference for patients.”

MPACT is the largest phase III clinical trial completed in advanced pancreatic cancer with more than 800 patients. Findings from the study showed a 59 percent increase in one-year median survival rates from less than a quarter of the patients (22 percent) to more than a third (35 percent). The two-year survival rate for this cancer is negligible, less than 4 percent, but that more than doubles (9 percent) with the nab-paclitaxel/gemcitabine combination.

One of those patients was Lynne Jacoby, 48, of Phoenix, who works as a director of compliance for a healthcare company. Jacoby was given only weeks to live when her Stage 4 pancreatic adenocarcinoma, a tumor the size of a golf ball, was first diagnosed in April 2012 — nine months ago.

“If you had to live your life in a year, and that is all the time you have, wouldn’t you do everything you could to experience this time,” said Jacoby, who for nearly a year before her diagnosis had experienced night sweats, indigestion, stomach pains, neck and back pain, and an elevated white-blood count.

She began the treatment of Abraxane plus gemcitabine in May 2012 and continues on the medications, saying now that she “feels awesome, wonderful.” She is scheduled to remain on the drug combination through May 2013.

“Life is priceless. No amount of money can be placed on life. I know I would be gone already if it was not for Dr. Von Hoff,” said Jacoby, who also refers to him as “Dr. Von Hope.”

The study showed significant improvement among some of the sickest patients including those with increased metastases. Significantly there was no increase in life-threatening toxicity. Other drug combinations that have demonstrated benefit have been limited by increased toxicities.

“This is a major improvement in a cancer with the lowest survival rates among all cancer types,” said Dr. Ramesh Ramanathan, medical director of Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the clinical trial in the United States. “Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is difficult to diagnose with a majority of the cases diagnosed at a late stage after the disease has already advanced.”

Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor sees as food. The tumor uses various mechanisms to preferentially attract the albumin, which then acts like a “Trojan Horse” to release its package of chemotherapy inside the tumor. It is approved in the U.S. for metastatic breast cancer and non-small cell lung cancer.

The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars.

The incidence of pancreatic cancer is increasing worldwide with an estimated 279,000 cases per year, including nearly 44,000 in the U.S. in 2012, and resulting in more than 37,000 American deaths last year.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at: 480-323-1339; toll free at 1-877-273-3713; or via email at clinicaltrials@shc.org.