PepCan for Head Neoplasms

1
Effectiveness
1
Safety
University of Arkansas for Medical Sciences, Little Rock, AR
Head Neoplasms+1 More
PepCan - Biological
Eligibility
18+
All Sexes
Eligible conditions
Head Neoplasms

Study Summary

This study is evaluating whether a new drug may help reduce the risk of cancer returning in individuals who have had cancer in the past.

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Eligible Conditions

  • Head Neoplasms
  • Head and Neck Neoplasms
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

2 years
Adverse events - evaluate safety of a 7-injection regimen of PepCan.
Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo
PepCan
Placebo group

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.

PepCan
Biological
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
Placebo
Biological
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

University of Arkansas for Medical Sciences - Little Rock, AR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The acceptable respiratory rate is 12 to 25 breaths per minute. show original
, who have not had major surgery or radiation therapy to the head and neck within the previous 60 days, and who are not receiving active therapy are eligible to participate in this study show original
patients The performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 patients is good. show original
means that there is no evidence of disease present at the time of the evaluation show original
Vital Signs recorded
The following text is about blood pressure show original
50-100 heartbeats per minute is an acceptable heart rate. show original
A low temperature is acceptable. show original
Able to provide informed consent
People aged 18 or over who are male or female. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can head neoplasms be cured?

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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.

Unverified Answer

What are common treatments for head neoplasms?

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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.

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What are the signs of head neoplasms?

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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.

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What is head neoplasms?

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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.

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How many people get head neoplasms a year in the United States?

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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.

Unverified Answer

What causes head neoplasms?

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Different types of neoplasms, including most of the head and neck, breast, gastrointestinal, lung, ovary and thyroid, are the most common malignancies. They mainly appear because of cigarette smoking.

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How serious can head neoplasms be?

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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/).

Unverified Answer

Has pepcan proven to be more effective than a placebo?

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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.

Unverified Answer

What does pepcan usually treat?

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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.

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Have there been other clinical trials involving pepcan?

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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.

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How quickly does head neoplasms spread?

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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.

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Who should consider clinical trials for head neoplasms?

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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.

Unverified Answer
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