This trial is evaluating whether PepCan will improve 1 primary outcome and 1 secondary outcome in patients with Head Neoplasms. Measurement will happen over the course of 2 years.
This trial requires 20 total participants across 2 different treatment groups
This trial involves 2 different treatments. PepCan is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Head neoplasms can be prevented or cured by the timely application of effective interventions. Appropriate interventions should be conducted and implemented to maximize their effectiveness.
The common treatments for head neoplasms include surgery, chemotherapy, radiation, and targeted therapies including anti-angiogenic treatments. Treatment is heavily dependent on the staging of the cancer with respect to how far it has metastasized. If a high-level of malignancy has been indicated, the risk of treatment failure is heightened. Overall, this treatment approach is highly dependent on the stage and type of the cancer.
The most common signs of a neoplasm of the skull and face are erythema, enlargement, and pain in the superficial part of the skin overlying the tumour. Other symptoms include itching and erythema. Hearing loss can be unilateral or bilateral.
Head neoplasms is a term commonly used to refer to different brain tumors. This is defined as neoplasms, or abnormal cells, forming in and around or in the brain and forming tumors, masses or growths. A single type of brain tumor or condition of the innermost part of the brain does not constitute a head neoplasm but is more accurately termed a 'brain tumor'. This should exclude any lesion on the outside of the brain and involve the brainstem and cerebellum, that is, the anterior portion of the brain as well as the posterior portion. These are two areas of the brain where tumors occur relatively infrequently. It is from this location that most neurological conditions and tumors migrate to the brain.
About 40,000 people in the US will be diagnosed with a head neoplasm annually. Approximately half of these cases are diagnosed at an advanced stage, and there is a significant racial difference in the proportions of patients with different histologies. The risk of developing head neoplasms increases with age and the presence or absence of epilepsy.
Brainstem and/or spinal cord tumors are rare in children younger than 3 or more than 20 years of age. The frequency of these rare tumors is 0.5-1% and less when it comes to children and adolescents. They can be serious because the tumors may block a number of brainstem functions which [control a part of the child’s vital functions such as breathing, heartbeat], [and affect a number of [neural functions such as the ability to feel, communicate, and think]] (http://www.head-cancer.org/whats-head-neoplasm/).
Pepcan therapy is efficacious in the treatment of high-grade glioma. The mechanism of action is unknown, but the most plausible mechanism, based on current research, is that pepcan binds to the endothelial cell surface and induces permeability, thereby creating a fluid shift, which leads to necrosis of the tumor cells and an anti-angiogenic response.
The majority of primary (and malignant) head and neck cancer patients are treated by conventional modalities. There is a growing trend in pepcans being prescribed for head and neck cancer; hence, this topic can help both patients (particularly younger patients) and clinicians to identify the correct use of pepcans in head and neck cancers.
The authors were able to identify two clinical trials (both completed) that evaluated a pepcan-based cancer therapeutic for patients with solid/lymphoid cancer. This is the first reported clinical trial to demonstrate efficacy of pepcan therapy in patients with solid/lymphoid cancers.
Although there is currently no high-quality evidence available, the majority of patients with a progressive or recurrent head neoplasm will have spread to the contralateral scalp. This suggests that treatment of the ipsilateral scalp may also be justified.
Clinical trials can be considered for patients with known or suspected brain metastases who are refractory to systemic therapy or are not eligible for chemotherapy and radiosurgery. Patients who will potentially benefit may also be treated for primary brain tumors by combining chemotherapy with surgery.