Combination of chemotherapy and electromagnetic fields for metastatic pancreatic cancer

A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer

This study is testing whether combining standard chemotherapy with a special device that uses electromagnetic fields can help people with advanced pancreatic cancer live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: THERABIONIC INC. (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT05776524 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of combining standard chemotherapy drugs, nab-paclitaxel and gemcitabine, with amplitude-modulated radiofrequency electromagnetic fields using the TheraBionic device in patients with metastatic adenocarcinoma of the pancreas. The primary goal is to assess the efficacy of this combination in improving overall survival rates over six months. Additionally, the study will monitor safety, tolerability, progression-free survival, objective response rate, and disease control rate among participants. Patients will be closely monitored through imaging studies to evaluate their response to treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, untreated metastatic adenocarcinoma of the pancreas.

Not a fit: Patients with non-adenocarcinoma pancreatic tumors or those who have received prior treatment for metastatic pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with metastatic pancreatic cancer.

How similar studies have performed: While the combination of chemotherapy with electromagnetic fields is a novel approach, similar studies have shown promise in other cancer types, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Pancreatic tumors with mixed histology that has predominant adenocarcinoma can be enrolled.
* One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis.
* Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Age 18 years old or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Patients must have organ and marrow function as defined below:

Organ and Marrow Function Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets\* ≥ 100,000/mcL Hemoglobin\* ≥ 7 g/dL \*It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.

Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (≤ 5 x ULN, if liver metastasis) Creatinine ≤ 1.5 X institutional upper limit of normal Or CrCL \> 50

\- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

* Patients treated with any chemotherapy in metastatic setting and/or who had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting are excluded. Patients who have had chemotherapy with FOLFIRINOX prior to entering the study in the adjuvant or neo-adjuvant setting can be enrolled into the study.
* Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel.
* History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
* Patients receiving calcium channel blockers and any agent blocking L-type of T type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.
* Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is completed.
* Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or could compromise patient safety.
* Known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.
* Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy and amplitude-modulated radiofrequency electromagnetic fields, patients who are breastfeeding will be excluded to participate in this study.
* Localized resectable or locally advanced tumor.
* Undergone surgery, other than diagnostic surgery or minor procedures, within 4 weeks prior to the treatment day.
* Unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.
* Actively enrolled in any other clinical interventional trial or receiving any other investigational agents.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Ravi Paluri, MD — Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Study Coordinator

Conditions: Pancreatic Cancer, Metastatic Adenocarcinoma