Long Island Jewish Medical Center on the Forefront of Aerosolized Chemotherapy Treatment Trial

Long Island Jewish Medical Center on the Forefront of Aerosolized Chemotherapy Treatment Trial

An entirely new way of administering chemotherapy that combines both a minimally invasive surgery and an actual aerosol sprayed directly onto the tumor is now under investigation at the prominent Long Island Jewish (LIJ) Medical Center (part of Northwell Health) in partnership with Northwell Health Cancer Institute. Recently, a patient here, 74-year old Anita Wolf of Lake Grove, NY, became the first treated with this novel approach. Known as pressurized intraperitoneal aerosol chemotherapy (PIPAC), the novel treatment technique administers the chemotherapy laparoscopically in the form of a pressurized aerosol. Designed for patients with end-stage peritoneal surface malignancy (cancer deposits on the thin layer of tissue that lines and covers the stomach, intestines, and most of the other organs within). The clinical trial, sponsored by City of Hope in California, features prominent collaboration involving Northwell Health as the New York-based health system’s Richard Whelan’s work attracted the trial. 

TrialSite provides a brief summary breakdown of this novel therapy now in use at LIJ, part of Northwell Health. 

Is this part of a bigger study?

Yes.

Who is the Sponsor?

City of Hope

What is this study?

An  early-stage, Phase 1 study (NCT04329494) investigates the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis).  

While drugs such as cisplatin, doxorubicin, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, PIPAC is a minimally invasive procedure involving the administration of intraperitoneal chemotherapy. 

The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). 

Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.

Study Details?

This Phase 1 study is planned to include 16 participants.  It started August 20 and is scheduled to run till March 8, 2022. The study primary outcome involves assessment of dose limiting toxicities (DLTs) during an 18 week period. This measurement criteria is assessed by Common Terminology Criteria for Adverse Events version 5.0 and includes a summary by type (e.g. organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility of outcome.

A number of secondary outcomes can be reviewed here. Eligibility criteria is complex and involves end-stage situations. 

How does this novel approach work?

During PIPAC, surgeons inject medication into the patient’s abdominal cavity through a nebulizer, which is inserted through a laparoscopic port (less than an inch in diameter). The nebulizer turns the liquid medicine into a fine mist. Importantly, PIPAC can be combined with IV chemotherapy in which case the tumor is being attacked from several directions. City of Hope, a comprehensive cancer center near Los Angeles, is the lead investigator of the national, multisite clinical trial testing the efficacy of PIPAC.

When is PIPAC most often used?

According to Dr. Whelan as covered in Northwell Health’s press release, the PIPAC is most often employed when cancer in the patient’s digestive system or in the case of a woman, female reproductive organs, spreads to the lining of the intestines and abdominal cavity. It may be an option for patients with stomach, ovarian, colorectal, or appendix cancer if surgery to remove the cancer is not an option. PIPAC in this trial will be given 3 times to each patient at 6 week intervals. And, because the procedures are laparoscopic, the patients spend more time at home since they can usually go home the day after the PIPAC treatment.

What is the patient’s journey here?

Ms. Wolf was an optimal candidate for PIPAC. Already a survivor of open-heart surgery in 2007, Ms. Wolf’s journey with cancer of the colon began in October 2019, when her daughter, Jennifer, urged her mother to go for a routine colonoscopy. The results were disappointing; Ms. Wolf was diagnosed with a stage 2A colon cancer that was soon surgically removed. 

However further CAT scans in January 2020 found irregular masses on her liver, which meant that the cancer had spread. Her oncologist recommended a three-months of chemotherapy. After that treatment, Ms. Wolf underwent liver resection surgery in June followed by more chemotherapy.

Unfortunately, later tests revealed that the cancer had spread to the lining of the intestine and abdomen. Colorectal cancer accounts for the second-most cancer deaths in the United States. Ms. Wolf was told about the possibility of participating in a clinical trial in June that was being developed to help people who were running out of options with traditional treatments of these types of cancers.

Does Long Island Jewish have a connection to this approach?

Yes. The research of Richard Whelan, MD, was instrumental to bringing the trial to LIJ.

What’s Dr. Whelan’s point of view on the study?

This is an entirely new way of giving chemotherapy that combines minimally invasive surgery and an aerosol of chemo that is sprayed directly onto the surface of a tumor,” reports the Long Island Jewish doctor. He continued, “This technique provides many advantages to patients living with certain types of cancer; basically, it’s a simple minimally invasive procedure that takes less than an hour. Best of all, it has fewer side effects than the traditional method of providing chemotherapy because the drugs are not injected into the bloodstream but instead are directly applied to the tumor deposits.”

An Incredibly Strong & Positive Patient 

Danielle DePeralta, MD, is the surgical oncologist following Ms. Wolf’s care and was part of the surgical team, alongside Dr. Whelan who performed the PIPAC surgery on February 8th.

Dr. DePeralta was quoted in Northwell Health’s press release, “At the time of her colon cancer diagnosis in 2019, the hope was for cure, but the cancer returned- first in the liver and then the peritoneum. Fortunately, the liver tumor could be removed, but the areas of spread in the peritoneum continued to grow despite intensive chemotherapy.” She continued, “Through all of her treatment, Ms. Wolf never seems to complain and manages to keep a positive attitude. Every time I see her, she says she feels great. She is a loving and courageous wife and mother. She is motivated both to control her own cancer, but also to contribute to our understanding of this disease so that we can better treat patients.”

Returning to the Northwell Cancer Institute on March 8th, International Women’s Day, Ms. Wolf exemplifies an example of courage and strength in the face of the scariest adversity. 

When asked about participating in a clinical trial for her illness, Ms. Wolf said, “I am honored to have the opportunity to do this. Hopefully, the knowledge acquired from my experience will help doctors and other patients in the future who are battling these forms of cancer.”

Lead Research/Investigator

Thanh H. Dellinger, MD, Principal Investigator, City of Hope 

Mustafa Raoof, MD, Principal Investigator, City of Hope

Richard L. Whelan, MD, Principal Investigator Northwell Cancer Institute. Note, Dr. Whelan runs his own practice as well. 

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