By Matt Burgard

Memorial Sloan Kettering clinical trials are now available for Hartford HealthCare Cancer Institute patients.

As part of the Hartford HealthCare Cancer Institute’s pioneering membership in the Memorial Sloan Kettering (MSK) Cancer Alliance, an increasing number of MSK’s cancer clinical trials and protocols are now being offered to cancer patients who receive care within the Institute.

That means promising and potentially groundbreaking advances in cancer research and treatment are being made available to patients without requiring them to go to New York City, where MSK is located and where previously patients had to travel to gain access to MSK’s world-renowned bank of trials and protocols.

The rollout of MSK clinical trials to patients within Hartford HealthCare is a cornerstone the Institute’s membership in the Alliance. As of July 2016, the Institute had made MSK-originated clinical trials and research protocols available to patients who are being cared at any of the five cancer centers that make up the Cancer Institute – Hartford Hospital, Backus Hospital, Windham Hospital, The Hospital of Central Connecticut and MidState Medical Center. Additional trials and studies are expected to be opened to patients over the next several months. (Watch the video below with Dr. Peter Yu, the Cancer Institute’s new physician in chief.)

So far, MSK trials have been opened to patients for the treatment of a variety of cancer types, including breast cancer, bladder cancer, pancreatic cancer and ovarian cancer, as well as multiple myeloma. Upcoming studies are expected to be opened for patients with colorectal and lung cancer as well as Hodgkin’s and non-Hodgkin lymphoma. An increasing number of the studies and trials are being made available at sites across the Institute.

Among the newly opened research studies is a genomic sequencing study sponsored by both the Institute and MSK which aims to determine the frequency of “actionable” oncogenic mutations in patients with advanced solid or hematologic tumors being evaluated for a therapeutic protocol. Whole genome sequencing for cancer has undergone an evolution and with every passing year, there are an increasing number of somatic mutations that are linked to specific tumor types.

The MSK trials are being made available in addition to a wide array of promising trials and research protocols now being offered to patients as part of the Institute’s Cancer Clinical Research Office, which are conducted by physicians and research specialists at the various cancer centers within the Institute.

“Our goal is to add to our existing portfolio of studies and to offer a comprehensive array of clinical trials for patients with common and uncommon cancers treated at the Hartford HealthCare Cancer Institute,” said Ellen Dornelas, PhD, Director of the Cancer Clinical Research Office.

To stay updated on the list, please visit the Hartford HealthCare Cancer Institute website.

The List: Clinical Trials 

Gynecologic Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Number: (HIPEC) 12-275
This is a Phase II randomized clinical trial meant to determine if performing a complex surgical procedure called hyperthermic intraperitoneal chemotherapy (HIPEC), along with standard post-operative surgery, is more effective in fighting gynecologic cancer than standard post-operative chemotherapy alone.
Who’s eligible: Patients who have had a first recurrence of ovarian, fallopian tube, or primary peritoneal cancer that initially responded to platinum-based therapy and which returned more than 6 and less than 30 months after completing that therapy.
Patients must be candidates for a second surgery to remove cancerous tissue in the abdomen.
The cancerous tissue remaining after the second surgery should be less than 5mm in size.
Patients may not have had prior chemotherapy for recurrent disease, nor any previous radiation therapy to the pelvis.
This study is open to patients age 21 and older.
Available at: Hartford Hospital.

Urinary Tract
Sponsor: Memorial Sloan Kettering Cancer Center
Number: 10-208
Some patients with bladder cancer have better outcomes if they receive chemotherapy before they undergo surgery. In this Phase III study, researchers want to see if this approach, called neoadjuvant chemotherapy, can lead to improved outcomes for patients.
Who’s eligible: Patients must have high-grade transitional cell carcinoma of the upper urinary tract (kidney/ureter) and be candidates for nephrectomy (kidney removal).
Patients may not have had prior radiation therapy or chemotherapy for their urothelial cancer.
Patients must be age 18 or older.
Available at: Hartford Hospital.

Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Number: 140124
This is an advanced Phase II study of various drugs to treat a metastatic form of breast cancer that produces the HER2 protein which provides messaging to cancer cells encouraging them to grow. It includes trastuzumab, gemcitabine and pertuzumab as a follow-up treatment to trastuzumab/pertuzumab therapy, and is meant to obstruct the HER2 messaging.
Who’s eligible: Patients must be women with metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients may not have had more than three regimens of chemotherapy for metastatic cancer. If they already received gemcitabine, it may not have been combined with pertuzumab.
Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
This study is for women age 18 and older.
Available at: Backus Hospital, The Hospital of Central Connecticut, Hartford Hospital.

Myeloma

Sponsor: Memorial Sloan Kettering Cancer Center
Number: 13-064
Bortezomib, dexamethasone, and lenalidomide are drugs which are often given together to treat newly diagnosed multiple myeloma (a cancer of the bone marrow). However, this combination of three drugs is associated with significant side effects. Doctors may be able to achieve the same results using only two drugs and add the third drug only in patients who do not respond to the two-drug combination.
In this study, researchers will first give patients just two of the drugs (bortezomib and dexamethasone). Patients will only receive lenalidomide if their myeloma is not well controlled with bortezomib and dexamethasone alone. Doctors hope that giving the myeloma drugs in this way will be as effective as using all three drugs at the same time from the beginning, but with less side effects.
Who’s eligible: Patients must be newly diagnosed with symptomatic multiple myeloma and may not have received prior treatment. Patients must be able to be ambulatory for more than half of their normal waking hours.
This study is open to patients age 18 and older.
Available at: Backus Hospital, MidState Medical Center, The Hospital of Central Connecticut, Hartford Hospital.

Pancreatic Cancer

Sponsor: Memorial Sloan Kettering Cancer Center
Number: 12-078
Gemcitabine is a drug which is routinely used to treat pancreatic cancer, but many patients still succumb to the disease. In this study, researchers want to evaluate the safety and effectiveness of combining an investigational drug called M402, a blood thinner, with gemcitabine in patients with previously untreated metastatic pancreatic cancer. In this study, a modified form of M402 (which has less blood-thinning properties) is being used, and laboratory studies have shown that it has anticancer effects. The goal of the initial part of the study is to find the highest dose of M402 that can be given safely with gemcitabine in patients. M402 is an injection that patients (or their caregivers) can give themselves at home. Gemcitabine is given intravenously in the clinic.
Who’s eligible: Patients must have previously untreated metastatic pancreatic adenocarcinoma. Patients with blood clotting disorders and those on blood thinners may not be able to participate. Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
Patients must be age 18 or older.
Available at: MidState Medical Center, The Hospital of Central Connecticut, Hartford Hospital.

Bladder Cancer

Sponsor: Memorial Sloan Kettering Cancer Center
Number: 15-291
Bladder cancers that invade the muscle wall of the bladder have a high risk of returning. Patients with these cancers typically have their bladders removed and are then monitored to see if the cancer comes back. In this study, researchers want to see if the drug atezolizumab can reduce the risk of cancer recurrence after bladder removal surgery for muscle-invasive bladder cancer.
Atezolizumab is a form of immunotherapy. It is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is approved for treating advanced bladder cancer; its use in this study is considered investigational.
Atezolizumab is given intravenously. Patients in this study will be randomly assigned to receive atezolizumab or observation only (no treatment).
Who’s eligible: Patients must have muscle-invasive bladder cancer and have surgery to remove the bladder. Patients may have had chemotherapy or radiation therapy before surgery, but not after surgery. At least 3 weeks must pass between completion of prior therapy and entry into the study. Patients must have declined or must not be eligible to receive adjuvant chemotherapy with cisplatin.
Patients must be able to be walk and do routine activities for more than half of their normal waking hours. This study is for patients age 18 and older.
Available at: MidState Medical Center, The Hospital of Central Connecticut, Hartford Hospital

Head/Neck Cancer

Sponsor: Memorial Sloan Kettering Cancer Center
Number: 15-245
The treatment of head and neck cancers can sometimes leave survivors with problems such as dry mouth, difficulty swallowing, or other long-term side effects that may affect their quality of life. Researchers are interested in learning more about how survivors of head and neck cancers feel after their treatment is completed. Memorial Sloan Kettering has created a survivors’ self-assessment tool for this purpose called “HN-STAR.”
In this study, researchers are asking survivors of head and neck cancers to use a web-based tool to report their symptoms and report their experience with this method of communication. The responses from the patient assessment are used to develop an individualized appointment with a cancer survivorship nurse practitioner who will give personalized recommendations. The responses from the assessment and clinic visit will automatically generate a survivorship care plan. The study assesses the feasibility of this process in clinical practice and assesses the patients and providers experience with this novel tool.
Who’s eligible: Participants in this study include people who were treated for head and neck cancer at least one year before entering the study and have no evidence of disease. Participants must be age 18 or older and be able to speak and read English.
Available at: Hartford Hospital